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CureVac Announces Developments in Patent Litigation with Pfizer/BioNTech
5/19/2023
Motion to transfer U.S. litigation to Eastern District of Virginia granted at CureVac's request and expected to significantly accelerate U.S. litigation timeline.
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The U.S. Supreme Court unanimously ruled Amgen’s cholesterol drug Repatha patents invalid, ending a protracted legal battle with competitors Sanofi and Regeneron. -
A three-judge panel is reviewing the legal challenge to the FDA’s approval of mifepristone. Any action by the court may result in further appeals, and possibly another Supreme Court decision. -
U.S. District Court Upholds Final Judgment for XIFAXAN(R) 550 mg That Prevents FDA Approval of Norwich’s Abbreviated New Drug Application Until 2029
5/17/2023
Bausch Health Companies Inc. (NYSE/TSX:BHC), and its gastroenterology business Salix Pharmaceuticals, today announced that the U.S. District Court of Delaware in the matter of Salix Pharmaceuticals, LTD et al v. Norwich Pharmaceuticals, Inc., has denied Norwich Pharmaceuticals' motion to modify the Court's final judgment that prevents the U.S. Food and Drug Administration (FDA) from approving Norwich's abbreviated new drug application (ANDA) for XIFAXAN® (rifaximin) 550 mg before Oct. 2, 2029.
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The Federal Trade Commission filed a lawsuit Tuesday seeking an injunction to prevent Amgen’s buyout of Horizon Therapeutics, which the agency says would “entrench monopoly drugs.” -
The U.S. Supreme Court’s denial of Teva Pharmaceuticals’ appeal could have broad ramifications for the wider generics industry, for which “skinny labeling” is a common and accepted practice.
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Lawmakers on Thursday voted 18–3 to increase oversight of pharmacy benefit managers and limit their practice of spread pricing, when PBMs charge payers for drugs more than they pay pharmacies. -
The Chapter 11 bankruptcy was driven by increasing generic competition, declining profits and the unrelenting legal woes of its head Martin Shkreli, dubbed “Pharma Bro” in the media. -
CureDuchenne Ventures Invests in MyoGene Bio and its AAV-Delivered CRISPR/Cas9 Gene Editing Approach
5/11/2023
CureDuchenne Ventures announced funding for MyoGene Bio, LLC, a biotech company developing a novel gene editing therapy for Duchenne muscular dystrophy.
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The biopharma company scored two major wins on Tuesday: a court victory over HIV patent claims and an acquisition deal to expand its pipeline in cancer and inflammatory diseases. -
Stonegate Capital Partners Updates Coverage On Aemetis, Inc. (AMTX) Q1 2023
5/10/2023
Aemetis, Inc. (NASDAQ: AMTX): Stonegate Capital Partners updates coverage on Aemetis, Inc. (NASDAQ: AMTX). The full report can be accessed by clicking on the following link: Aemetis, Inc. Q1 2023 Report
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The proposed drug pricing legislations follow the Inflation Reduction Act, passed in August 2022. -
TRACON Pharmaceuticals Announces Arbitration Award in Dispute with I-Mab
4/25/2023
TRACON Pharmaceuticals, Inc. today announced that the tribunal in the arbitration against I-Mab conducted under the Rules of Arbitration of the International Chamber of Commerce (ICC) rendered an award to TRACON in the aggregate amount of approximately $23.0 million.
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Alkermes Announces Second Interim Award in Janssen Pharmaceutica Arbitration
4/25/2023
Alkermes plc (Nasdaq: ALKS) today announced that on April 19, 2023 it received a second interim award (the "Second Interim Award") from the arbitral tribunal (the "Tribunal") in its arbitration proceedings in respect of two license agreements with Janssen Pharmaceutica N.V.
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Friday, the Supreme Court granted the FDA’s application for a stay, effectively maintaining access to the abortion pill mifepristone as its case goes through the appeals process. -
Defence Granted US Patent with Broad Coverage on Accum(TM)-based Vaccine Enhancer Platform Technology
4/24/2023
Defence Therapeutics Inc. (CSE: DTC) (FSE: DTC) (OTC Pink: DTCFF) ("Defence" or the "Company"), a Canadian biopharmaceutical company developing novel immune-oncology vaccines and drug delivery technologies including Antibody Drug Conjugates ("ADCs"), is pleased to announce the issuance of its US patent no. 11,612,651 by the United States Patent and Trademark Office (USPTO).
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The Supreme Court extended the stay deadline to Friday at midnight to keep mifepristone on the market in the interim without conditions. -
The lawsuit, brought by Arbutus Biopharma, marks the latest legal action in an ongoing battle for intellectual property underlying mRNA vaccines for COVID-19.
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In an open letter published Monday, more than 480 biopharma industry leaders expressed their support for the FDA after a Texas federal judge ruled to hold the approval of the abortion pill mifepristone. -
A California judge denied Elizabeth Holmes’ motion for release pending appeal, ruling that the former Theranos CEO must serve her prison sentence while she appeals her guilty verdict.