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Troubled AMAG Pharmaceuticals taps Scott Myers as CEO and president; Cheryl Blanchard secures CEO title at Anika Therapeutics

Troubled AMAG Pharmaceuticals taps Scott Myers as CEO and president; Cheryl Blanchard secures CEO title at Anika Therapeutics

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Scott Myers

AMAG Pharmaceuticals has found a successor for William Heiden, who was ousted in January. Scott Myers will be the new president and CEO of the embattled biotech, which saw the approval for its preterm birth drug Makena get pulled by the FDA. Myers arrives at AMAG from Rainier Therapeutics, where he was chairman and CEO. He’s also been CEO, president and director of Cascadian Therapeutics and CEO of Aerocrine AB.

Cheryl Blanchard

Cheryl Blanchard has shed the interim CEO label and is now the president and CEO of Anika Therapeutics. Blanchard stepped into the role at the Massachusetts biotech, which targets regenerative medicine, in February after the passing of Joseph Darling. A member of Anika’s board of directors for two years, Blanchard was president and CEO of Microchips Biotech until it was sold to Daré Bioscience in November.

→ As Endpoints News reported, Kelly Martin is running a biotech again. The former head of Elan Pharmaceuticals, Martin succeeds Jesper Hoeiland as president and CEO of Radius Health, which has seen its stock price slump since its osteoporosis drug Tymlos entered the fray. Before his 12-year tenure at Elan, Martin spent more than two decades at Merrill Lynch. His last gig was running Novan, a penny stock player which recently signaled the need to review strategic options.

→ CAR-T pioneer Carl June can add to his list of accolades. The esteemed University of Pennsylvania professor is one of 120 members, along with 26 international members, to be elected this week into the new class of the National Academy of Sciences.

Kyle Kuvalanka

→ Changes to the leadership team have been made at Goldfinch Bio, which appointed Kyle Kuvalanka as CFO and COO, while promoting Lori Rudolph-Owen to chief development officer. Kuvalanka has held positions at Syros Pharmaceuticals (COO and principal financial and accounting officer) and Blueprint Medicines (CBO and principal financial and accounting officer). Rudolph-Owen joined Goldfinch two years ago as SVP of R&D strategy and operations.

→ After selecting Rami Levin as the new CEO in January, Saniona is bringing in Rudolf Baumgartner to be CMO and head of clinical development. Before his arrival at the biopharma, which focuses on the treatment of diseases in the central nervous system, Baumgartner was CMO for the Flatley Discovery Lab, a non-profit foundation working in cystic fibrosis. He was also EVP and CMO for Inotek Pharmaceuticals.

David Cook

→ Regrouping after severing ties with Celgene, Forma Therapeutics has chosen David Cook to be SVP and CSO. Prior to joining Forma, Cook was the CSO for Seres Therapeutics, playing a key role in the strategy and fundraising in the microbiome field. Additionally, he’s been the COO for the International AIDS Vaccine Initiative (IAVI).

→ Danish biotech Galecto, which has an inhaled galectin-3 modulator for idiopathic pulmonary fibrosis in its pipeline, has welcomed Jonathan Freve as CFO. He jumps to Galecto from Spring Bank Pharmaceuticals, where he was CFO and treasurer. He was also the senior director of finance at Santaris Pharma until its acquisition by Roche.

Ludovic Robin

Ludovic Robin will be CBO at Oslo-based PCI Biotech, which focuses on treatment of cancer through its photochemical internalization (PCI) technology platform. He jumps on board from Advicenne, where he was CBO and deputy CEO, and is also a Shire vet who was with the biopharma for 12 years.

→ Having received $100 million in funding in March, Xilio has appointed Martin Huber as CMO. Prior to his arrival at Xilio, which focuses on IL-2 and CTLA4 immunotherapies, Huber led the expansion of the niraparib program as SVP and CMO at Tesaro. He’s also been the VP, oncology clinical research at Merck Research Laboratories.

→ After promoting Ian Clements to CFO in January, Mirum Pharmaceuticals has a new COO in Peter Radovich. Before heading to the San Diego biopharma, which regained control of liver disease drugs maralixibat and volixibat from Shire in 2018, Radovich was EVP, operations, at Global Blood Therapeutics.

Manja Boerman

→ Teaming up with J&J on a Covid-19 vaccine candidate, Catalent has also announced some new leadership. Manja Boerman will assume the role of president, cell & gene therapy, effective June 1. She replaces the retiring Pete Buzy, who will stay on as chairman of Catalent gene therapy as he aids in the transition. Previously, Boerman was president of Aesica Pharmaceuticals. Additionally, Mario Gargiulo has signed on as the company’s region president, biologics (Europe).

→ Medical cannabis business Trulieve has tapped Alex D’Amico as CFO effective June 1. In the meantime, the company’s controller and director of financial reporting, Ryan Blust will serve as interim CFO. Most recently, D’Amico served as VP finance/controller for Telaria and previously held posts at Cognizant, Quest Diagnostics and Synvista Therapeutics.

Randolph Legg has moved to the position of head of US commercial business at Boehringer Ingelheim Animal Health. Previously, Legg served as head of US pet vet business at Boehringer Ingelheim and has held various sales and commercial operations roles in the company’s human pharmaceutical division during his 25-year stint with the company.

Targovax ASA, which focuses on immuno-oncology, has pegged Victor Levitsky as CSO. Levitsky had previously been VP, head of oncology research at Molecular Partners in Zurich, and was also tumor immunology leader and senior principal scientist at Roche.

Joe Miller

→ With encouraging data in its hip pocket for lupus nephritis drug voclosporin, Aurinia has reeled in Joe Miller as CFO. For the last two years, Miller had been at Cerecor as CFO, principal executive officer, and corporate secretary. Prior to Cerecor, he was VP of finance at Sucampo Pharmaceuticals.

→ Beijing-based CANbridge Pharmaceuticals has named Richard Gregory as its acting CSO and will also join the board of directors. Most recently, Gregory has been EVP and CSO at ImmunoGen and has previously been head of the Sanofi-Genzyme R&D Center.

→ British life-science VC Syncona has selected Danny Bar-Zohar as partner. In his 7 years at Novartis, Bar-Zohar rose to become the pharma giant’s global head, clinical development & analytics. Before Novartis, he was also at Teva Pharmaceuticals in several roles.

Laura Shawver

→ The just-named president and CEO of Silverback Therapeutics, Laura Shawver, will also be on the board of directors at Nkarta. Joining her on the board this week is Leone Patterson, the president, CEO and director of Adverum Biotechnologies.

→ With a lead drug (COR388) in an ongoing Phase II/III clinical study in patients with mild to moderate Alzheimer’s disease, Cortexyme will bring Caryn McDowell on board as chief legal and administrative officer and corporate secretary, effective May 11. McDowell makes the leap from Revance, where she was SVP, general counsel and corporate secretary.

Mycovia, which is testing its therapy VT-1161 for patients with recurrent vulvovaginal candidiasis (RVVC), has named Susan McGaurn as senior director of medical affairs. McGaurn was previously at Endo Pharmaceuticals as their director, medical information and call centers.

Savitha Ram Moorthi

→ As of June 1, Savitha Ram Moorthi will be head of global quality management at Swiss biotech Basilea Pharmaceutica. Ram Moorthi started at Basilea Feb. 1 as head of quality compliance systems & safety after 25 years in numerous roles at Novo Nordisk.

Bob Laughner is taking over as VP, regulatory affairs at Orchestra BioMed. He joins the leadership team after almost two years at AstraZeneca as regulatory director, medical device and combination products.

Brian Walter has moved to CNS disease-focused Relmada Therapeutics to become its VP, regulatory affairs after holding the same position at RegenxBio. Before his time at RegenxBio, Walter was executive director of regulatory affairs at Regeneron.

→ South San Francisco-based Atara Biotherapeutics, which targets allogeneic T-cell immunotherapies, has tapped Ron Renaud as director and non-executive chair of the board of directors. Renaud has been CEO of Translate Bio — recently partnering with Sanofi on an mRNA program for Covid-19 — since 2014.

Halley Gilbert

ADC Therapeutics, which just re-filed for a $100 million IPO this week, is bringing in Victor Sandor to be on its board of directors. Sandor was CMO at Array BioPharma, and before that, he was SVP for global clinical development at Incyte.

Halley Gilbert has joined the board of directors at California-based immuno-dermatology biopharma Arcutis Therapeutics. Most recently, Gilbert has been SVP for corporate development and chief administrative officer at Ironwood Pharmaceuticals.

Christopher Coughlin has landed a seat on the board of directors at Karuna Therapeutics, which expressed optimism in its schizophrenic drug data in November. Currently, the lead independent director of Allergan, Coughlin was EVP and CFO of Tyco International.

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International

Beloved mall retailer files Chapter 7 bankruptcy, will liquidate

The struggling chain has given up the fight and will close hundreds of stores around the world.

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It has been a brutal period for several popular retailers. The fallout from the covid pandemic and a challenging economic environment have pushed numerous chains into bankruptcy with Tuesday Morning, Christmas Tree Shops, and Bed Bath & Beyond all moving from Chapter 11 to Chapter 7 bankruptcy liquidation.

In all three of those cases, the companies faced clear financial pressures that led to inventory problems and vendors demanding faster, or even upfront payment. That creates a sort of inevitability.

Related: Beloved retailer finds life after bankruptcy, new famous owner

When a retailer faces financial pressure it sets off a cycle where vendors become wary of selling them items. That leads to barren shelves and no ability for the chain to sell its way out of its financial problems. 

Once that happens bankruptcy generally becomes the only option. Sometimes that means a Chapter 11 filing which gives the company a chance to negotiate with its creditors. In some cases, deals can be worked out where vendors extend longer terms or even forgive some debts, and banks offer an extension of loan terms.

In other cases, new funding can be secured which assuages vendor concerns or the company might be taken over by its vendors. Sometimes, as was the case with David's Bridal, a new owner steps in, adds new money, and makes deals with creditors in order to give the company a new lease on life.

It's rare that a retailer moves directly into Chapter 7 bankruptcy and decides to liquidate without trying to find a new source of funding.

Mall traffic has varied depending upon the type of mall.

Image source: Getty Images

The Body Shop has bad news for customers  

The Body Shop has been in a very public fight for survival. Fears began when the company closed half of its locations in the United Kingdom. That was followed by a bankruptcy-style filing in Canada and an abrupt closure of its U.S. stores on March 4.

"The Canadian subsidiary of the global beauty and cosmetics brand announced it has started restructuring proceedings by filing a Notice of Intention (NOI) to Make a Proposal pursuant to the Bankruptcy and Insolvency Act (Canada). In the same release, the company said that, as of March 1, 2024, The Body Shop US Limited has ceased operations," Chain Store Age reported.

A message on the company's U.S. website shared a simple message that does not appear to be the entire story.

"We're currently undergoing planned maintenance, but don't worry we're due to be back online soon."

That same message is still on the company's website, but a new filing makes it clear that the site is not down for maintenance, it's down for good.

The Body Shop files for Chapter 7 bankruptcy

While the future appeared bleak for The Body Shop, fans of the brand held out hope that a savior would step in. That's not going to be the case. 

The Body Shop filed for Chapter 7 bankruptcy in the United States.

"The US arm of the ethical cosmetics group has ceased trading at its 50 outlets. On Saturday (March 9), it filed for Chapter 7 insolvency, under which assets are sold off to clear debts, putting about 400 jobs at risk including those in a distribution center that still holds millions of dollars worth of stock," The Guardian reported.

After its closure in the United States, the survival of the brand remains very much in doubt. About half of the chain's stores in the United Kingdom remain open along with its Australian stores. 

The future of those stores remains very much in doubt and the chain has shared that it needs new funding in order for them to continue operating.

The Body Shop did not respond to a request for comment from TheStreet.   

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Government

Are Voters Recoiling Against Disorder?

Are Voters Recoiling Against Disorder?

Authored by Michael Barone via The Epoch Times (emphasis ours),

The headlines coming out of the Super…

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Are Voters Recoiling Against Disorder?

Authored by Michael Barone via The Epoch Times (emphasis ours),

The headlines coming out of the Super Tuesday primaries have got it right. Barring cataclysmic changes, Donald Trump and Joe Biden will be the Republican and Democratic nominees for president in 2024.

(Left) President Joe Biden delivers remarks on canceling student debt at Culver City Julian Dixon Library in Culver City, Calif., on Feb. 21, 2024. (Right) Republican presidential candidate and former U.S. President Donald Trump stands on stage during a campaign event at Big League Dreams Las Vegas in Las Vegas, Nev., on Jan. 27, 2024. (Mario Tama/Getty Images; David Becker/Getty Images)

With Nikki Haley’s withdrawal, there will be no more significantly contested primaries or caucuses—the earliest both parties’ races have been over since something like the current primary-dominated system was put in place in 1972.

The primary results have spotlighted some of both nominees’ weaknesses.

Donald Trump lost high-income, high-educated constituencies, including the entire metro area—aka the Swamp. Many but by no means all Haley votes there were cast by Biden Democrats. Mr. Trump can’t afford to lose too many of the others in target states like Pennsylvania and Michigan.

Majorities and large minorities of voters in overwhelmingly Latino counties in Texas’s Rio Grande Valley and some in Houston voted against Joe Biden, and even more against Senate nominee Rep. Colin Allred (D-Texas).

Returns from Hispanic precincts in New Hampshire and Massachusetts show the same thing. Mr. Biden can’t afford to lose too many Latino votes in target states like Arizona and Georgia.

When Mr. Trump rode down that escalator in 2015, commentators assumed he’d repel Latinos. Instead, Latino voters nationally, and especially the closest eyewitnesses of Biden’s open-border policy, have been trending heavily Republican.

High-income liberal Democrats may sport lawn signs proclaiming, “In this house, we believe ... no human is illegal.” The logical consequence of that belief is an open border. But modest-income folks in border counties know that flows of illegal immigrants result in disorder, disease, and crime.

There is plenty of impatience with increased disorder in election returns below the presidential level. Consider Los Angeles County, America’s largest county, with nearly 10 million people, more people than 40 of the 50 states. It voted 71 percent for Mr. Biden in 2020.

Current returns show county District Attorney George Gascon winning only 21 percent of the vote in the nonpartisan primary. He’ll apparently face Republican Nathan Hochman, a critic of his liberal policies, in November.

Gascon, elected after the May 2020 death of counterfeit-passing suspect George Floyd in Minneapolis, is one of many county prosecutors supported by billionaire George Soros. His policies include not charging juveniles as adults, not seeking higher penalties for gang membership or use of firearms, and bringing fewer misdemeanor cases.

The predictable result has been increased car thefts, burglaries, and personal robberies. Some 120 assistant district attorneys have left the office, and there’s a backlog of 10,000 unprosecuted cases.

More than a dozen other Soros-backed and similarly liberal prosecutors have faced strong opposition or have left office.

St. Louis prosecutor Kim Gardner resigned last May amid lawsuits seeking her removal, Milwaukee’s John Chisholm retired in January, and Baltimore’s Marilyn Mosby was defeated in July 2022 and convicted of perjury in September 2023. Last November, Loudoun County, Virginia, voters (62 percent Biden) ousted liberal Buta Biberaj, who declined to prosecute a transgender student for assault, and in June 2022 voters in San Francisco (85 percent Biden) recalled famed radical Chesa Boudin.

Similarly, this Tuesday, voters in San Francisco passed ballot measures strengthening police powers and requiring treatment of drug-addicted welfare recipients.

In retrospect, it appears the Floyd video, appearing after three months of COVID-19 confinement, sparked a frenzied, even crazed reaction, especially among the highly educated and articulate. One fatal incident was seen as proof that America’s “systemic racism” was worse than ever and that police forces should be defunded and perhaps abolished.

2020 was “the year America went crazy,” I wrote in January 2021, a year in which police funding was actually cut by Democrats in New York, Los Angeles, San Francisco, Seattle, and Denver. A year in which young New York Times (NYT) staffers claimed they were endangered by the publication of Sen. Tom Cotton’s (R-Ark.) opinion article advocating calling in military forces if necessary to stop rioting, as had been done in Detroit in 1967 and Los Angeles in 1992. A craven NYT publisher even fired the editorial page editor for running the article.

Evidence of visible and tangible discontent with increasing violence and its consequences—barren and locked shelves in Manhattan chain drugstores, skyrocketing carjackings in Washington, D.C.—is as unmistakable in polls and election results as it is in daily life in large metropolitan areas. Maybe 2024 will turn out to be the year even liberal America stopped acting crazy.

Chaos and disorder work against incumbents, as they did in 1968 when Democrats saw their party’s popular vote fall from 61 percent to 43 percent.

Views expressed in this article are opinions of the author and do not necessarily reflect the views of The Epoch Times or ZeroHedge.

Tyler Durden Sat, 03/09/2024 - 23:20

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Government

Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The…

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Veterans Affairs Kept COVID-19 Vaccine Mandate In Place Without Evidence

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

The U.S. Department of Veterans Affairs (VA) reviewed no data when deciding in 2023 to keep its COVID-19 vaccine mandate in place.

Doses of a COVID-19 vaccine in Washington in a file image. (Jacquelyn Martin/Pool/AFP via Getty Images)

VA Secretary Denis McDonough said on May 1, 2023, that the end of many other federal mandates “will not impact current policies at the Department of Veterans Affairs.”

He said the mandate was remaining for VA health care personnel “to ensure the safety of veterans and our colleagues.”

Mr. McDonough did not cite any studies or other data. A VA spokesperson declined to provide any data that was reviewed when deciding not to rescind the mandate. The Epoch Times submitted a Freedom of Information Act for “all documents outlining which data was relied upon when establishing the mandate when deciding to keep the mandate in place.”

The agency searched for such data and did not find any.

The VA does not even attempt to justify its policies with science, because it can’t,” Leslie Manookian, president and founder of the Health Freedom Defense Fund, told The Epoch Times.

“The VA just trusts that the process and cost of challenging its unfounded policies is so onerous, most people are dissuaded from even trying,” she added.

The VA’s mandate remains in place to this day.

The VA’s website claims that vaccines “help protect you from getting severe illness” and “offer good protection against most COVID-19 variants,” pointing in part to observational data from the U.S. Centers for Disease Control and Prevention (CDC) that estimate the vaccines provide poor protection against symptomatic infection and transient shielding against hospitalization.

There have also been increasing concerns among outside scientists about confirmed side effects like heart inflammation—the VA hid a safety signal it detected for the inflammation—and possible side effects such as tinnitus, which shift the benefit-risk calculus.

President Joe Biden imposed a slate of COVID-19 vaccine mandates in 2021. The VA was the first federal agency to implement a mandate.

President Biden rescinded the mandates in May 2023, citing a drop in COVID-19 cases and hospitalizations. His administration maintains the choice to require vaccines was the right one and saved lives.

“Our administration’s vaccination requirements helped ensure the safety of workers in critical workforces including those in the healthcare and education sectors, protecting themselves and the populations they serve, and strengthening their ability to provide services without disruptions to operations,” the White House said.

Some experts said requiring vaccination meant many younger people were forced to get a vaccine despite the risks potentially outweighing the benefits, leaving fewer doses for older adults.

By mandating the vaccines to younger people and those with natural immunity from having had COVID, older people in the U.S. and other countries did not have access to them, and many people might have died because of that,” Martin Kulldorff, a professor of medicine on leave from Harvard Medical School, told The Epoch Times previously.

The VA was one of just a handful of agencies to keep its mandate in place following the removal of many federal mandates.

“At this time, the vaccine requirement will remain in effect for VA health care personnel, including VA psychologists, pharmacists, social workers, nursing assistants, physical therapists, respiratory therapists, peer specialists, medical support assistants, engineers, housekeepers, and other clinical, administrative, and infrastructure support employees,” Mr. McDonough wrote to VA employees at the time.

This also includes VA volunteers and contractors. Effectively, this means that any Veterans Health Administration (VHA) employee, volunteer, or contractor who works in VHA facilities, visits VHA facilities, or provides direct care to those we serve will still be subject to the vaccine requirement at this time,” he said. “We continue to monitor and discuss this requirement, and we will provide more information about the vaccination requirements for VA health care employees soon. As always, we will process requests for vaccination exceptions in accordance with applicable laws, regulations, and policies.”

The version of the shots cleared in the fall of 2022, and available through the fall of 2023, did not have any clinical trial data supporting them.

A new version was approved in the fall of 2023 because there were indications that the shots not only offered temporary protection but also that the level of protection was lower than what was observed during earlier stages of the pandemic.

Ms. Manookian, whose group has challenged several of the federal mandates, said that the mandate “illustrates the dangers of the administrative state and how these federal agencies have become a law unto themselves.”

Tyler Durden Sat, 03/09/2024 - 22:10

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