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Luba Greenwood takes the helm at Kojin Therapeutics, steering an all-female C-suite; Alexion R&D chief packs up for change of scenery at VC firm

Luba Greenwood
How rare is it to find a woman leading a micro- or small-cap biotech company? According to a recent survey, it happens less than 6% of the time. And all-female C-suites? Almost unheard of.
But on Thursday, Kojin Therapeutics officially…

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Luba Greenwood

How rare is it to find a woman leading a micro- or small-cap biotech company? According to a recent survey, it happens less than 6% of the time. And all-female C-suites? Almost unheard of.

But on Thursday, Kojin Therapeutics officially tapped Luba Greenwood as its first CEO, completing an all-female C-suite. All of the biotech’s senior scientists are women too, as is the scientific co-founder. It’s a moment that Greenwood always believed would come.

“I have always had a positive look that we will have women and minorities in senior positions,” she told Endpoints News Thursday. “It’s wonderful.”

Looking back at her career, Greenwood would separate her experience into buckets. She dipped her toes in the industry in 2004 as an associate at the law firm WilmerHale, where she represented pharmaceutical, biotech and medtech companies, among others. She’s always been interested in science — but it was while studying biology at Brandeis that a professor encouraged her to learn law.

She stayed at WilmerHale for just over seven years, before transitioning to Pfizer as senior counsel for M&A and corporate compliance. She would later work at another Big Pharma, Roche, as VP of global M&A and business development, and at Google’s life sciences research company Verily as head of strategic business development and corporate ventures.

She’s also dabbled in small companies, helping build startups in several spaces, including immunotherapy, women’s health, artificial intelligence, machine learning and microbiome. Most recently, she was a managing partner at the Dana-Farber Cancer Institute’s venture fund, Binney Street Capital, a venture arm she founded to support the development of treatments for incurable cancers.

“Ultimately I realized that innovation comes down to really two things: really amazing science and really amazing people,” she said.

Kojin’s roots trace back to Vasanthi Viswanathan, who was working as a postdoc in Harvard biochemist Stuart Schreiber’s lab when she demonstrated a “vulnerability” in cancer cells that don’t die after treatment.

Most targeted cancer drugs work by inducing cancer cells to undergo apoptosis: a standard, highly regulated form of cellular suicide. To survive, some cells turn off that apoptosis program. But Viswanathan showed, by throwing thousands of molecules at hundreds of drug-resistant or semi-drug-resistant cell lines, that this program relies on the cell churning out an abundance of fatty acids. And she showed that, in doing so, the cells become open to another form of cell death: ferroptosis, where toxins build up and eventually kill the cell.

That work culminated in Kojin, and though it’s still in early stages, the startup landed a $60 million Series A back in June. Since then, it’s probably doubled in size, Greenwood said.

What’s next for the serial entrepreneur? Cementing a positive culture at Kojin. That begins with a collaborative layout at the company’s new facility in Boston’s seaport — for example, no one (not even the CEO) will have a designated office.

“Hopefully you and I will speak in a year and we’ll be in consideration for one of the small best companies to work for,” Greenwood said.

Nicole DeFeudis


John Orloff

AstraZeneca sub Alexion ditched a Phase III study of Ultomiris in August that showed a “lack of efficacy” for ALS after the drug hit its primary endpoint a month earlier in Phase III for generalized myasthenia gravis. But that’s all in the past now for John Orloff, whose next act will be as a venture partner for Agent Capital, a life sciences investment firm founded by Geeta Vemuri. Orloff replaced Martin Mackay — the current CEO of Rallybio — as Alexion’s R&D chief in 2017 after holding the same title at Baxalta and Novelion Therapeutics.

After his departure from Alexion, Orloff also clinched a spot on the board of directors at BenevolentAI.

Ann Lee

→ The David Liu-founded gene editing player Prime Medicine, singled out for this year’s Endpoints 11 and backed by bigwigs like ARCH’s Bob Nelsen and GV’s David Schenkein in a supersized $315 million raise, has appointed Ann Lee as chief technical officer. Lee’s career has been dotted with Big Pharma stops, most recently at Bristol Myers Squibb, where she was SVP and head of cell therapy development and operations (CTDO). Lee spent 14 years at Merck Research Laboratories through the 1990s and early 2000s, and in 2005 she joined Genentech as VP of process R&D, later taking on the role of SVP and head of global technical development at Roche.

Rita Jain made a speedy exit within months of becoming Immunovant’s CMO in January, but she’s a medical chief again at Chemocentryx, which just notched an approval for its ANCA-associated vasculitis drug Tavneos last week by a razor-thin margin. This appears to be a no-brainer for CEO Thomas Schall and his team: Jain knows Chemocentryx well as a member of the board of directors with the company since March 2019. Before her lightning-quick stay at Immunovant, Jain held the CMO post at Akebia Therapeutics for two years and was AbbVie’s VP of men’s and women’s health and metabolic development.

Johanna Mylet

Poseida Therapeutics, which bagged a $3.6 billion nonviral gene therapy deal with Takeda earlier this week, has made a slew of fresh promotions to its leadership team with the appointments of Johanna Mylet (CFO), Devon Shedlock (CSO, cell therapies), Kristin Martin (chief people and administration officer), and Lisa Portale (SVP, regulatory affairs). Mylet hopped aboard the Poseida train in 2015 and most recently served as SVP, finance. Prior to her role with the San Diego-based company, Mylet was with HUYA Bioscience International and Grant Thornton. Shedlock most recently served as Poseida’s SVP of research & development. Shedlock made his way to Poseida after stints at the Perelman School of Medicine and UPenn’s T-Cell Engineering Laboratory.

Kristin Martin

Meanwhile, Martin formerly served as Poseida’s chief human resources officer and was previously VP of human resources, facilities and IT at Ardea Biosciences. Last, but not least, Portale jumped aboard Poseida in early 2019 as the company’s VP, regulatory affairs. Prior to that role, Portale was with Pfizer, Phenomix Corporation, Neurocrine Biosciences, Medtronic and Perrigo Company.

Paul Stoffels

→ The shift in J&J’s leadership just got more seismic this week with the retirement of chief scientist Paul Stoffels, who will step aside at the end of the year. Stoffels — who’s also the vice chairman of J&J’s executive committee — was the CEO of Virco and chairman of Tibotec when J&J bought both companies in 2002, and he’s been with the multinational ever since, getting elevated to CSO in 2012 and invigorating R&D thereafter. Stoffels would establish Johnson & Johnson Innovation and Johnson & Johnson Global Public Health to further cement his legacy. The Stoffels news comes after CEO Alex Gorsky announced his departure in August, passing the baton to Joaquin Duato and transitioning to the executive chairman post on Jan. 3.

Mary Beth Harler

IGM Biosciences has been busy with the creation of some new business units to expand on work areas such as autoimmune diseases and infectious diseases. And with those new units, the California-based company has snatched up a trio of experts from Big Pharma to lead them. John Shiver, the former SVP of vaccine R&D at Sanofi Pasteur, is joining IGM as chief strategy officer of its infectious disease unit. His colleague Tong-Ming Fu, who headed Sanofi Pasteur’s vaccine research in North America, will take up the chief scientific officer spot. Meanwhile, the IGM Autoimmunity and Inflammation department will be headed up by Mary Beth Harler, most recently head of immunology and fibrosis development at Bristol Myers Squibb.

Emile Nuwaysir, the former CEO of BlueRock Therapeutics, is stepping into the CEO spot at Ensoma — an ambitious and well-backed startup out of Fred Hutch and the University of Washington. In his new role, Nuwaysir will be tasked with making one of the oldest and most elusive goals in cell and gene therapy a reality: reprogramming blood cells with a simple infusion, an approach that could make CAR-T cancer treatments and transformative therapies for sickle cell and other rare blood disorders far safer, more scalable and more accessible. Nuwaysir brings with him experience from his times at NimbleGen Systems, Cellular Dynamics International and Invenra.

Mari Scheiffele

Ipsen has named Novartis alum Mari Scheiffele EVP and president, specialty care international, and her first day with the French biotech is scheduled for Nov. 1. Scheiffele pivots to Ipsen after spending three years as the general manager of UK & Ireland at Novartis Oncology, and was also part of the leadership in the specialty care business for Novartis Japan. In August, Ipsen strapped on the dealmaking boots by collaborating with Exicure on neuro diseases—namely Huntington’s and Angelman syndrome — for $20 million upfront.

Brendan Smith

→ On the heels of unloading data from its “off-the-shelf” CAR-T therapy for patients with B cell lymphoma, CRISPR Therapeutics is undergoing a CFO change with Michael Tomsicek’s retirement after four years at the Samarth Kulkarni-led biotech. He’s succeeded by Brendan Smith, ever-so-briefly the CFO at Translate Bio until Sanofi’s purchase of its partner for $3.2 billion in August. Smith wrapped up six years at Pfizer in 2016 as VP, head of business operations for worldwide R&D before joining Boston Consulting Group as a partner. Kulkarni expressed enthusiasm about the safety data for CTX110 with our Jason Mast on Tuesday, but questions remain over durability.

Theresa Heah

Shankar Ramaswamy’s gene therapy joint Kriya Therapeutics, which launched last year and lassoed a $100 million Series B haul led by Jim Momtazee in July, has welcomed Theresa Heah as CMO and president of the new ophthalmology division, Kriya Ophthalmology. Heah, formerly the CMO at AsclepiX and Applied Genetic Technologies Corporation, is a Sanofi and Allergan alum who also was global strategic marketing and tactical brand plan lead for Eylea at Bayer.

→ We have two promotions at Waltham, MA-based Minerva Neurosciences after the arrival of R&D chief Ramana Kuchibhatla, starting with CFO and CBO Geoff Race getting the bump to president. A member of the Nessan Bermingham-chaired board at F-star, Race made the sprint to Minerva as CFO in 2014 and tacked on the CBO title in 2016. He was also the CEO at Funxional Therapeutics before its 2012 acquisition by Boehringer Ingelheim. Next, the CFO role at Minerva is now in the hands of ex-chief accounting officer Frederick Ahlholm, who also came on board in 2014 after being Amarin’s VP of finance and chief accounting officer.

Dymeka Harrison

→ Following the appointments of CMO Mia Levy and chief biopharma business officer Sanket Agrawal this summer, Roche’s Foundation Medicine has selected Dymeka Harrison as chief commercial officer. Before her recent position as the strategic marketing head of Abbott Laboratories, Harrison filled a string of sales roles at Thermo Fisher, bioMérieux and Qiagen. Foundation Medicine’s headquarters will move into a 16-story building in Boston’s Seaport District that’s currently under construction, with the space expected to be ready by 2023.

Ashley Hall has signed on to be chief development officer at Southern California’s Reneo Pharmaceuticals, a mitochondrial disease biotech that received a $95 million boost in a Series B that Novo Ventures and Abingworth headlined in December 2020. According to an SEC filing, Hall changed roles from chief development officer to chief regulatory officer at Esperion in June, but only had the proverbial cup of coffee at that post before leaving for Reneo. Earlier, Hall was global regulatory lead, specifically for PCSK9 inhibitor Repatha, with Amgen.

Jason Haas

→ Following the appointment of chief commercial officer Conley Chee in late September, Syros has tapped Jason Haas as CFO. Before his most recent turn as co-head of Americas, healthcare investment banking for Barclays, Haas also led healthcare investment banking for the Americas at Deutsche Bank. Syros’ RARα agonist tamibarotene is in Phase II for acute myeloid leukemia (Phase II) and in Phase III for higher-risk myelodysplastic syndrome.

→ Citing personal reasons, Noah Rosenberg is on his way out as CMO of Travere Therapeutics, deciding instead on shifting to an executive advisor role that will take effect by the end of the year. Rosenberg, who has been the medical chief since 2018, is a Pfizer and Sanofi vet in medical affairs who previously owned the CMO title at Esperion. Removing all vestiges of “Pharma Bro” Martin Shkreli by erasing the Retrophin name almost a year ago, Travere joined forces with Vifor Pharma last month to commercialize its kidney drug sparsentan, a deal in which Vifor shelled out $55 million upfront.

Molly Painter

→ Speaking of Vifor, Lee Heeson (president, international) and Gregory Oakes (president, North America) have also announced their departures for personal reasons, while Molly Painter is about to apply the first brushstrokes to her Vifor canvas as president, US starting Monday. Painter comes to Vifor from Orphazyme, where she held the same post as she will here, and after three years at Shire she became VP, rare disease at Takeda in 2019. Elsewhere, she’s had marketing stints at Lundbeck and Baxalta.

Patrick Walsh is jumping over to Immunic, which back in February had its lead drug fail to impress in two separate trials, as CBO. Walsh brings to the table experience from his time at Akebia Therapeutics, where he served as VP of business development. Prior to that stint, Walsh was in corporate development at AVEO Oncology.

Clinton Musil is headed for the exits at Catalyst Biosciences, announcing his resignation as CFO of the South San Francisco biotech effective Oct. 29. We had him in this very space when he took the job on July 1, 2020, and the search is on for a replacement; meanwhile, Catalyst controller Seline Miller earns a promotion to SVP, finance and will also be interim chief financial and principal accounting officer.

Timothy Hunt

Filing for the $100 million IPO we’re so accustomed to nowadays, solid tumor-focused Xilio Therapeutics has installed Timothy Hunt as chief culture and corporate affairs officer. From 2016-20, Hunt held the role of chief corporate affairs officer at Editas Medicine, and he’s served as Cubist Pharmaceuticals’ SVP of public affairs. Peer Review also notes that, after getting promoted to the position in April, Ronan O’Hagan is out as Xilio’s CSO, according to his LinkedIn page.

→ Raleigh, NC-based RainBio, a gene therapy player concentrating on corneal diseases, has named Gary Sternberg its acting CEO. Sternberg, the founding CEO of Stargardt disease-focused Stargazer Pharmaceuticals, is the ex-CBO at Eleven Biotherapeutics who was therapeutic head of ophthalmic medical affairs for a time at Genentech, taking charge of US medical affairs for anti-VEGF blockbuster Lucentis.

Blake Aftab

→ Climbing the ranks at allogeneic gamma delta T cell therapy player Adicet Bio, Blake Aftab has been promoted to SVP and CSO. Aftab began serving as the biotech’s VP and head of research in April, and prior to his stint at Adicet, he was VP and head of preclinical science and translational medicine at Atara Biotherapeutics.

Amir Shojaei

→ With Theresa Heah setting off for Kriya and first-year CEO Robert Dempsey at the controls, Baltimore-based eye disease biotech AsclepiX has now brought on Amir Shojaei as CSO and EVP, clinical development. Shojaei was Dempsey’s chief development officer at TearClear and helmed eye-focused TherOptix, which is now led by Aurion Biotech founder Monty Montoya. Prior to these positions, he was therapeutic area head of ophthalmology at Shire and Takeda.

→ San Diego-based Kite cell therapy partner Shoreline Biosciences is bringing on Scott Forrest as CBO. Back in January, we covered his promotion from CBO to CFO at Autobahn Therapeutics. Forrest, who co-founded ARCH-backed BlackThorn Therapeutics, has also served as COO and CFO at Inception Therapeutics.

Jennifer Evans Stacey

Galera Therapeutics out of Pennsylvania has a pair of new C-suiters, welcoming chief commercial officer Mark Bachleda and chief legal and compliance officer Jennifer Evans Stacey. Bachleda played a key role in the launches of Breyanzi and Abecma at Bristol Myers as VP & US business unit head for the CAR-T franchise. He’s also been VP of sales at Juno Therapeutics and he ended his 15-year association with Amgen in 2017 as the general manager of Amgen Czech Republic. Evans Stacey moves on to Galera after five years as the Wistar Institute’s VP, general counsel, secretary and government relations. Looking to tamp down the effects of radiation, Galera’s lead drug avasopasem manganese is in Phase III for head and neck cancer patients with radiotherapy-induced severe oral mucositis (SOM).

Gene Mack

Gene Mack has signed on to be CFO of Houston neuro startup Coya Therapeutics, which launched in February with a nothing-too-fancy Series A and the Treg research of Stanley Appel to guide them. The CFO at OncoImmune before Merck purchased it in one of Roger Perlmutter’s final deals, Mack was also the finance lead at OncoImmune spinout OncoC4.

Troels Koch

Eli Lilly’s saRNA partner MiNA Therapeutics has greeted a quartet of new execs, and tuning up first is SVP of chemistry Troels Koch, the former VP and head of research at Roche Innovation Center Copenhagen. Next, Julia Vassiliadou (VP, clinical operations) makes her way to MiNA after 19 years with GlaxoSmithKline, where she recently served as global head of in-country clinical operations. Also joining Robert Habib’s squad is Ilian Tchakov, MiNA’s VP of clinical development who brings Big Pharma credentials from Lilly, Roche, AstraZeneca and was Eisai’s head of oncology global early clinical development. Lastly, Kevin Fettes (VP, CMC and quality operations) has been a VP in similar capacities with Galena and Dicerna.

→ As Synairgen gets in gear for regulatory submissions on SNG001, its inhaled interferon beta candidate to treat Covid-19, Roche vet Gareth Walters is stepping in as the UK company’s first chief regulatory officer. During his seven years at Chugai Pharmaceuticals, Walters was head of European regulatory affairs and, before joining Synairgen, global regulatory affairs head (research & early development).

Veit Schmelmer

→ Joining forces with J&J in a stem cell collaboration they hope can bear fruit in the treatment of acute myeloid leukemia, Vor Biopharma has paved the way for Veit Schmelmer to be SVP of program and alliance management. An 11-year vet in drug development at Takeda — namely Entyvio — Schmelmer was previously the project lead for MGTA-145 at Magenta, and from 2017-19 he was VP of portfolio strategy for Mersana Therapeutics.

Steffen Hellmold has been appointed to the newly created role of SVP, business development, data storage at San Francisco-based synbio specialist Twist Bioscience. Before joining Emily Leproust‘s team at Twist, Hellmold was VP of corporate strategic initiatives at Western Digital. He also served as VP of marketing at Everspin Technologies.

Sara Turken

→ With a study looming to determine if CRISPR gene editing can cure HIV — earning the FDA’s seal of approval last month — Excision BioTherapeutics has brought in three more staffers. Sara Turken (general counsel) just closed out her three years at Rocket Pharmaceuticals as head of legal, compliance officer & corporate secretary; Manish Anand (SVP, regulatory affairs) has past regulatory experience from such companies as BioMarin, Portola and Cellectis, and since last summer he had been AskBio’s VP of regulatory affairs; and Robert Gunning (VP, controller) comes to Excision from his CFO post at Novartis sub Advanced Accelerator Applications, where he was also head of finance transformation.

→ As Vish Seshadri prepares for his opportunity to take charge as CEO at Abeona, the gene and cell therapy player has recruited Jon Voss as VP, head of quality. The erstwhile EVP of global quality at Cellectis, a position he held since 2019, Voss has also been a quality control exec at Generation Bio and Sarepta. The drug furthest along at Abeona is EB-101 for recessive dystrophic epidermolysis bullosa.

John Tomtishen

→ Life sciences tech company Cellares has appointed John Tomtishen as VP of operations. Before joining Cellares, Tomtishen was site managing director of Legend Biotech’s corporate headquarters. Over the summer, Cellares nabbed $100 million in funding for its Cell Shuttle and partnered with Poseida as a therapy provider.

Ken Song’s RayzeBio, which snagged a nine-figure Series C round in June to bring its total funding to $258 million, has enlisted Genentech alum Rozalyn Littler as VP of regulatory and quality. Littler also brings regulatory experience from Prometheus Laboratories, Heron Therapeutics and Metacrine. One more RayzeBio note: Nektar SVP and executive clinical fellow Mary Tagliaferri now has a seat on a board of directors that also includes Versant’s Jerel Davis and venBio’s Aaron Royston.

Susan Silbermann

→ Longtime Pfizer alum Susan Silbermann has been elected to the board of directors at Perceptive’s LianBio a week after Michael Humphries was named chief scientific advisor. Silbermann, who just retired from Pfizer (a move several of her other colleagues have either made or intend to make), chaired the pharma giant’s Covid-19 task force and had been global president, emerging markets. In addition, J&J vet Jesse Wu has also joined LianBio’s board.

Intarcia president and CEO Kurt Graves has been named executive chairman of ionic liquids biotech i2O Therapeutics. Graves, who has helmed and chaired Intarcia since 2012, was also chairman of the board at Radius Health from 2011-20.

Kathleen Tregoning

→ After signing a $125 million licensing agreement with HealthCare Royalty Partners last month, Spero Therapeutics has added Kathleen Tregoning to its board of directors. Tregoning currently serves as the chief corporate affairs officer at Cerevel. Before joining Cerevel, she held the EVP of external affairs position at Sanofi.

Bob Duggan has turned to Ken Clark as the newest board member at Summit Therapeutics a few weeks after the FDA raised objections to the primary endpoint for its C. difficile drug ridinilazole. Clark, who was behind the scenes of AbbVie’s $21 billion deal to buy Duggan’s old company Pharmacyclics, is a partner at Wilson Sonsini Goodrich & Rosati.

Olivier Danos

→ Using a gene therapy approach for eye diseases and topping off its Series B financing this summer, French biotech Coave Therapeutics — once known as Horamahas added Olivier Danos and Frederic Chereau to its board of directors. Danos is the CSO at Regenxbio, and Chereau has been CEO at LogicBio for the last five years.

Emily Rollins is now a member of the board of directors at Science 37, which is doing a SPAC dance after merging with LifeSci Acquisition II Corp. last week. Rollins, who will chair the audit committee at Science 37, is an ex-audit and assurance partner at Deloitte.

→ The new vacant seat on the supervisory board at InteRNA Technologies has been secured by former Aduro Biotech CSO Andrea van Elsas. Van Elsas succeeds Mark Vaeck, who stepped down. Currently, van Elsas is a venture partner with Third Rock Ventures and has previously served in roles at Merck, Organon and BioNovion.

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Shkreli’s former company pays $40m in price-gouging settlement

A pharma company formerly led by ‘pharma bro’ Martin Shkreli has settled a long-running lawsuit with the US
The post Shkreli’s former company pays $40m in price-gouging settlement appeared first on .

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A pharma company formerly led by ‘pharma bro’ Martin Shkreli has settled a long-running lawsuit with the US federal government over massive price increases for an off-patent drug treatment for people with an HIV-related disease.

Vyera Pharma – known as Turing Pharma when the scandal first emerged several years ago – will pay $40 million in settlement of the charges that it raised the price of Daraprim (pyrimethamine) for toxoplasmosis, a life-threatening parasitic infection that affects people with HIV, by around 4,000%.

Shkreli himself is already serving a seven-year prison term for securities fraud, and will have to answer the same accusations in a trial that is due to start next week.

He had been dubbed “the most hated man in America” for his arrogant and defiant posturing whilst acting as chief executive of Turing after the company’s decision to raise the price of the drug hit headlines around the world.

At the moment Shkreli is scheduled for release in October 2022, after an attempt last year to secure an early release to fight the coronavirus epidemic – branded as “delusional” by the judge who considered the request – was turned down.

The Vyera agreement was revealed in a Federal Trade Commission (FTC) statement yesterday , which said that Shkreli masterminded the scheme to fleece patients dependent on Daraprim.

His company not only raised the price from $17.50 to $750 per tablet – leaving some patients forced to pay up to $16,000 in out-of-pocket co-pays – but also “concocted an elaborate web of restrictions to illegally block competitors from producing a cheaper option,” it said.

The order bans Shkreli’s associate Kevin Mulleady – Vyera’s former CEO – from working in the pharma industry for seven years, and requires Vyera and its Swiss parent Phoenixus to pay $10 million upfront in relief to victims, with another $30 million payable over the next 10 years “if the companies’ financial condition improves.”

The companies are also required to make Daraprim available to any potential generic competitor at list price.

Vyera had previously said the FTC’s actions were “without merit” and it denied claims that it  prevented additional potential competitors from entering the market. It has now agreed not to participate in any activity that might mirror the actions laid out in the FTC’s complaint.

“Today’s action puts money back in the pockets of drug patients fleeced by a monopolistic scheme,” said FTC chair Lina Khan.

“This strong relief sets a new standard and puts corporate leaders on notice that they will face severe consequences for ripping off the public by wantonly monopolising markets,” she added.

The post Shkreli’s former company pays $40m in price-gouging settlement appeared first on .

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U.S. FDA authorizes use of AstraZeneca COVID-19 antibody cocktail

The U.S. Food and Drug Administration on December 8 authorized the use of AstraZeneca’s antibody cocktail to prevent Covid-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines.

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U.S. FDA authorizes use of AstraZeneca COVID-19 antibody cocktail

(Reuters) – The U.S. Food and Drug Administration on Wednesday authorized the use of AstraZeneca’s (AZN.L) antibody cocktail to prevent COVID-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines.

The antibody cocktail, Evusheld, is only authorized for adults and adolescents who are not currently infected with the novel coronavirus and have not recently been exposed to an infected individual, the regulator said.

The logo for AstraZeneca is seen outside its North America headquarters in Wilmington, Delaware, U.S., March 22, 2021. REUTERS/Rachel Wisniewski/File Photo

The authorization for the therapy, made up of two monoclonal antibodies tixagevimab and cilgavimab, marks a significant step for AstraZeneca, whose widely used COVID-19 vaccine is yet to be approved by U.S. authorities.

AstraZeneca last month had agreed to supply the U.S. government with 700,000 doses of Evusheld, which had earlier shown to cut the risk of people developing any COVID-19 symptoms by 77% in a late-stage trial.

While vaccines rely on an intact immune system to develop targeted antibodies and infection-fighting cells, Evusheld contains lab-made antibodies designed to linger in the body for months to contain the virus in case of an infection.

AstraZeneca’s therapy, given in two sequential injections, is designed to last several months to a year.

Although vaccines currently provide the best defense against COVID-19, certain immune compromised individuals or those who have a history of severe adverse reactions to a vaccine need an alternative prevention option, said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

However, the FDA added that pre-exposure prevention with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.

Monoclonal antibodies aim to stop COVID-19 from worsening during early, milder stages. Drugmakers such as Eli Lilly (LLY.N), Regeneron (REGN.O), and GlaxoSmithKline (GSK.L) with partner Vir (VIR.O) make similar therapies.

Reporting by Manas Mishra and Bhanvi Satija in Bengaluru; Editing by Shounak Dasgupta

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-authorizes-astrazenecas-covid-19-antibody-drug-2021-12-08

 

 

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Life Sciences Expansions Take Off as 2021 Wraps Up

Several life sciences companies and life science-focused real estate firms announced expansion plans as 2021 comes to an end.

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Life Sciences Expansions Take Off as 2021 Wraps Up

Several life sciences companies and life science-focused real estate firms have announced expansion plans as 2021 comes to an end. Here’s a look.

Novavax to Expand Maryland Campus

Novavax, on the cusp of getting its COVID-19 vaccine authorized in numerous countries around the world, is expanding its footprint in Gaithersburg, Md., where it is headquartered. The European Medicines Agency (EMA) is expected to authorize the company’s vaccine soon, and so is the U.S. Food and Drug Administration (FDA). Czechia has already ordered 370,000 doses, with deliveries expected at the beginning of 2022. The company also has a deal with Fujifilm Diosynth Biotechnologies to manufacture millions of doses of the Novavax vaccines at its facilities in Billingham, U.K., with a £400 million investment in expansion.

Four Corners Acquired 150,000-Square-Foot Complex in Belmont, Calif.

Four Corners Properties acquired a 150,000-square-foot office building in Belmont, Calif., called the Shoreway Innovation Center. The seller was Westlake Group. Westlake bought it in 2016 for $61 million. The company plans to expand its use for life sciences, noting that 82% of it is currently leased to a mix of tenants with an average of less than three years lease term remaining.

“Shoreway Innovation Center offers the opportunity to bring office and life sciences space to a market where tenant demand is far outpacing available supply,” said Mike Taquino, executive vice president of CBRE’s Northern California Capital Markets team.

Genentech Leases Building Under Construction in South San Francisco

Source: BioSpace

Boston Properties and Alexandria Real Estate Equities are leasing a building under construction in South San Francisco to Genentech. It will be the first phase of a life sciences campus. The building is at 751 Gateway and is 229,000 square feet. The campus will be called Gateway Commons and is a joint venture between the two real estate firms. They expect initial occupancy toward the end of 2024. Genentech has been headquartered in South San Francisco for forty years, with a large corporate headquarters made up of 4.7 million square feet of five neighborhood hubs. The new site is about one mile’s distance from their main campus.

Mispro Biotech to Open New Facility in North Carolina in Early 2022

Mispro Biotech Services plans to open a new facility in Research Triangle Park (RTP), N.C., in early 2022. Mispro is a leading contract vivarium organization (CVO). The new facility, a full-service vivarium research facility, will be central to one of RTP’s biopark campuses.

“Since we first opened our doors here in 2013, we have seen incredible growth in the RTP cluster,” said Philippe Lamarre, chief executive officer of Mispro. “The time was right to expand into a new facility with more space and modern amenities where we can support the influx of biotechs who are seeking in vivo lab space.”

Laura Gunter, president of NCBIO, representing the life sciences industry in North Carolina, noted, “Mispro has become a cornerstone of the Triangle ecosystem as contract research and support companies are finding increased favor. Biotechs of all sizes and therapeutic disciplines are focusing more on their core competencies, which is opening the door to innovation like Mispro’s contract vivarium option. We are pleased to see their decision to expand here and support more North Carolina companies.”

BioSpace source:

https://www.biospace.com/article/life-science-companies-announce-expansion-plans-as-they-wrap-up-2021

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