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Thursday, January 2, 2025

Federal Judge Rules For Pfizer In Lawsuit Over Company's COVID-19 Vaccine

 by Zachary Stieber via The Epoch Times,

A federal judge has thrown out a lawsuit brought by Texas against Pfizer, finding that U.S. law protects Pfizer due to the emergency declared over the COVID-19 pandemic.

Several laws shield Pfizer from claims that it misrepresented the efficacy of its vaccine, U.S. District Judge Sam R. Cummings said in the Dec. 30 ruling.

“The Court finds that as a matter of law under the circumstances of this case, the Defendant is entitled to immunity under the Public Readiness and Emergency Act (PREP Act),” Cummings wrote.

He also said that both the PREP Act and the Food, Drug, and Cosmetic Act, preempt the allegations from Texas.

Texas Attorney General Ken Paxton in 2023 brought the suit in county court, alleging Pfizer misrepresented the results of the clinical trial that tested its COVID-19 vaccine.

Pfizer and its partner promoted the vaccine as 95 percent effective against COVID-19 infection, but the companies relied on just two months of trial data.

“Of 17,000 placebo recipients, only 162 acquired COVID-19 during this two-month period. Based on those numbers, vaccination status had a negligible impact on whether a trial participant contracted COVID-19,” the suit stated.

“The risk of acquiring COVID-19 was so small in the first instance during this short window that Pfizer’s vaccine only fractionally improved a person’s risk of infection.”

Texas officials accused Pfizer of violating several laws, including the Food, Drug, and Cosmetic Act, that prohibit misleading advertising.

Pfizer removed the case to federal court and said in court filings that it was protected against the suit by the PREP Act.

The act states in part that it grants immunity “from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure,” with narrow exceptions, during an emergency.

The U.S. health secretary declared an emergency over COVID-19 in 2020. Immunity for vaccine makers was recently extended through 2029.

“The statute provides immunity from claims for ‘any type of loss’ related to the administration or use of Pfizer’s vaccine,” Pfizer lawyers wrote in a brief in support of the company’s motion to dismiss the case, quoting from a ruling in a separate case.

“The claims here fall squarely within this broad definition of ‘loss.’”

Texas lawyers said in response that the PREP Act does not shield Pfizer in part because Congress did not preempt state claims against drug manufacturers.

“The State’s Complaint contains well-pled factual allegations focusing on Pfizer’s gross misrepresentations to the public about specific aspects of its vaccine’s performance, and that is not preempted,” they told Cummings.

Cummings sided with Pfizer in his brief ruling, which concluded by saying the case was dismissed “for essentially the reasons argued in the Motion and Reply” from Pfizer.

Paxton’s office and Pfizer did not respond to requests for comment.

https://www.zerohedge.com/political/federal-judge-rules-pfizer-lawsuit-over-companys-covid-19-vaccine

iBio Expands Obesity Program With New Antibody Using In-Licensed Platform

 On Thursday, iBio, Inc. (NYSE:IBIO) expanded its cardiometabolic and obesity treatment development program by in-licensing a potentially long-acting anti-myostatin antibody from AstralBio, Inc.

In March, iBio collaborated with AstralBio to discover, engineer, and develop antibodies to treat obesity and other cardiometabolic conditions.

The antibody, now named IBIO-600, was identified by AstralBio using iBio’s proprietary technology stack. It was designed for subcutaneous administration and has the potential for an extended half-life.

AstralBio will receive an upfront payment of $750,000, which iBio has paid by issuing its common stock to AstralBio.

In addition, AstralBio will be eligible for development and commercialization milestone payments totaling up to $28 million.

If iBio sublicenses the licensed product, AstralBio will receive low to mid-single-digit sublicense fees on the proceeds of the sublicense fees.

iBio is solely responsible for the research and development, manufacturing, and commercialization activities of the licensed product.

In parallel, iBio initiated a bispecific antibody program targeting myostatin/activin A to treat obesity and cardiometabolic disorders, leveraging its proprietary Drug Discovery Platform and the technology of IBIO-600.

The myostatin licensing agreement and planned myostatin/activin A bispecific antibody program follows a drug discovery and development collaboration between iBio and AstralBio initiated less than a year ago.


https://finance.yahoo.com/news/nano-cap-ibio-expands-obesity-142418635.html

NRX: Kadima Neuropsychiatry Institute Expected First Acquisition

 

  • Kadima Neuropsychiatry Institute in La Jolla, CA to serve as flagship for an international network of clinics dedicated to treating depression and PTSD
  • Kadima's founder, David Feifel, MD, PhD, Professor Emeritus of Psychiatry at University of California San Diego, a pioneer in advanced interventional treatments for neuropsychiatric conditions such as depression and PTSD, to join Hope as Chief Medical Innovation Officer
  • Kadima is a leading investigative site for CNS and psychedelic research, and has served as the lead site in nearly all major clinical trials in this area
  • Acquisition expected to be immediately accretive to revenue and EBITDA for NRx

ANI Approval and Launch of Prucalopride Tablets with 180-Day CGT Exclusivity

 ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company has launched Prucalopride Tablets. ANI’s Prucalopride Tablets is the generic version of the reference listed drug (RLD) Motegrity®.

https://www.globenewswire.com/news-release/2025/01/02/3003434/0/en/ANI-Pharmaceuticals-Announces-the-FDA-Approval-and-Launch-of-Prucalopride-Tablets-with-180-Day-CGT-Exclusivity.html

Capricor Completes Submission of Biologics License Application for Treatment of Duchenne

 -If approved, deramiocel would be first approved therapy for Duchenne muscular dystrophy cardiomyopathy-

-BLA submission triggers $10 million milestone payment to Capricor from Nippon Shinyaku-

https://www.globenewswire.com/news-release/2025/01/02/3003570/0/en/Capricor-Therapeutics-Completes-Submission-of-Biologics-License-Application-to-the-U-S-FDA-for-Deramiocel-for-the-Treatment-of-Duchenne-Muscular-Dystrophy.html

Carmell to Acquire Elevai Physician Dispensed Exosome Skin and Hair Care Products

 PMGC Holdings Inc (NASDAQ: ELAB), a diversified holding company, and Carmell Corporation (Nasdaq: CTCX), a bio-aesthetics company focused on skin and hair health (“Carmell”, the “Company”, “we”, “our”, or “us”), today announced that it entered into a definitive purchase agreement with PMGC Holdings Inc. (formerly Elevai Labs Inc.) and its wholly owned subsidiary, Elevai Skincare Inc. (“Elevai”), to acquire the assets related to its skincare and haircare business (the “Acquisition”).

The purchase consideration for the Acquisition is as follows:

  • Approximately $1.1 million in Carmell common stock at the closing of the Acquisition (the “Closing”);
  • Approximately $57,000 in cash upon the sale of specified inventory existing as of the Closing;
  • Contingent earnout consideration consisting of:
    • 5% of net sales from Elevai’s existing products paid annually during the 5-year period following the Closing, and
    • a one-time milestone payment of $500,000 if Elevai’s hair and scalp products achieve $500,000 in net revenue within 24 months following the Closing; and
  • Carmell’s assumption of contractual liabilities and trade payables of Elevai at the Closing.

As part of the Acquisition, Carmell expects to acquire the following assets of Elevai:

  • Product portfolio with trailing twelve-month revenue of approximately $2.5 million;
  • Commercial and product development team;
  • Finished and work-in-process inventory of approximately $1.0 million; and
  • Accounts receivable of approximately $0.03 million.

Pfizer Joins Forces with Atavistik Bio on Cancer Treatments

 Pfizer (NYSE:PFE) js teaming up with Atavistik Bio, leveraging the smaller company's AMPS platform to develop precision allosteric therapeutics. The focus: Tackling two undisclosed, Pfizer-designated targets that could revolutionize treatment in oncology and beyond. While the financials are not disclosed, Pfizer has the option to license these programs once the research phase concludes, highlighting just how high the stakes are.


Atavistik Bio is bringing its game with the AMPS platform, described as a highly integrated discovery engine that unlocks functional cryptic pockets across a broad range of target classes. CEO Bryan Stuart emphasized, Allostery holds the key to targeting disease-causing proteins and delivering highly selective, better tolerated, and more effective therapies. The deal is also a boost for Atavistik's own pipeline, with its lead oncology candidate, ATV-1601, anticipated to enter clinical trials in early 2025.


https://finance.yahoo.com/news/pfizer-joins-forces-atavistik-bio-163824799.html