In a lawsuit filed in federal court in Missouri, USA, Health insurer Cigna (NYSE: CI) and its pharmacy benefit manager (PBM) Express Scripts demanded that the Federal Trade Commission (FTC) retract its July 2024 report. 18 September 2024
Several pharma companies that had moved the Delhi High Court against the government’s recent notification banning 156 fixed-dose combination (FDC) drugs have got a breather. 10 September 2024
Glenmark Pharmaceuticals has agreed to pay $25 million, based on its ability to pay, to resolve its alleged liability under the False Claims Act for conspiring to fix the price of a generic drug, the US Department of Justice announced. 5 September 2024
German pharma major Bayer has filed a lawsuit against the Russian drugmaker Promomed to protect the patent rights for Xarelto (rivaroxaban), its treatment for stroke prevention which is the best-selling drug in the Russian market at present, The Pharma Letter’s local correspondent reports. 2 September 2024
Regeneron Pharmaceuticals has filed a lawsuit against Sandoz, alleging that its biosimilar to Eylea (aflibercept) infringes certain patents. 29 August 2024
Liquidia Corporation announced Thursday that it has filed litigation in the US District Court of the District of Columbia (Case No. 1:24-cv-02428) that challenges the recent decision by the US Food and Drug Administration (FDA) to grant three-year new clinical investigation (NCI) exclusivity to Tyvaso (treprostinil) DPI.9.6. 23 August 2024
Ardelyx has filed a lawsuit against the US Department of Health and Human Services DHSS) and the Centers for Medicare and Medicaid Services (CMS), regarding its Xpohzah. 19 July 2024
India's Zydus Lifesciences has been barred by the Delhi High Court from selling its breast cancer drug, Sigrima, a biosimilar version of Roche's pertuzumab (brand name Perjeta). 12 July 2024
Efforts to end US business deals with certain foreign biotechs considered threats are gaining traction again, with House Speaker Mike Johnson stating his intention to hold a vote on the BIOSECURE act this year. 11 July 2024
Viatris has announced that the antitrust division of the US Department of Justice (DOJ) has concluded its investigation into Mylan and its former president, Rajiv Malik. 3 July 2024
pharma.be, the umbrella organization of innovative biopharma companies active in Belgium, has highlighted the publication of the Transparency Register 2023. 1 July 2024
The European Commission (EC) has accused privately-held API manufacturer Alchem International of breaching European Union antitrust rules by participating in a long-lasting cartel concerning an important pharmaceutical product. 14 June 2024
A New Jersey, USA, federal judge has ruled that five patents covering Israel-based Teva Pharmaceutical Industries-brand asthma inhalers were improperly listed in the Food and Drug Administration’s (FDA) Orange Book, in a win for US drugmaker Amneal Pharmaceuticals. 12 June 2024
Last week, the US Court of Appeals for the District of Columbia (DC) ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program, noted Sophia Gaulkin and Alan Kirschenbaum of law firm Hyman Phelps & McNamara. 1 June 2024
UK-based Alliance Pharma (AIM: APH) has successfully appealed against a Competition and Markets Authority (CMA) ruling that had found the company guilty of breaching competition law. 24 May 2024
Sanofi this morning announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) in connection with Sanofi's intent to acquire Medivation. 14 June 2016
Leading Russian biotech firm Biocad has filed a petition to the New York Federal Court against Swiss pharma giant Roche, accusing the company of setting monopoly-low prices for its products in Russia, with the aim of ruining business of local competitors, reports The Pharma Letter’s local correspondent. 14 June 2016
Drug pricing was on Wall Street’s mind again Friday, as Wells Fargo tapped Netherlands-incorporated Mylan as the next target for activists, reported Investor’s Business Daily. 13 June 2016
By Barbara Obstoj-Cardwell. Editor
Sarepta Therapeutics and top officials at the US Food and Drug Administration are working cooperatively to approve the Duchenne muscular dystrophy drug eteplirsen, wrote Adam Feuerstein on TheStreet blog. 12 June 2016
A judge in the USA has freed biotech major Gilead Sciences from having to pay $200 million over allegedly infringing the hepatitis C patents of Merck & Co. 7 June 2016
UK based Indivior on Friday received a favorable ruling in the District Court of Delaware in the ANDA litigation against Actavis Laboratories and Par Pharmaceutical relating to Suboxone (buprenorphine and naloxone) its treatment for opioid addiction. 4 June 2016
The UK’s Competition and Markets Authority (CMA) has told The Pharma Letter that it continues to investigate suspected excessive pricing in the pharmaceutical industry. 3 June 2016
US specialty pharma firm Egalet says it has reached an agreement with Purdue Pharma as it relates to alleged patent infringements against Egalet and product licensor Acura Pharmaceuticals for Oxaydo (oxycodone HCl, USP) tablets CII. 23 May 2016
Japanese drugmaker Chugai Pharmaceutical has revealed that a lawsuit was filed against the company at the Tokyo District Court by US biotechnology firm Baxalta. 12 May 2016
In our weekly expert view piece Dr Nick Meyers, programme director at Boyd Consultants examines the implications what the regulatory and legislative landscape in the biopharmaceutical industry could look like post-Brexit. 10 May 2016
Canada’s Valeant Pharmaceuticals International has formed a new Patient Access and Pricing Committee that will be responsible for the pricing of the company's drugs. 6 May 2016
The US Department of Justice revealed yesterday that pharma giant Pfizer and its legacy company Wyeth have agreed to pay $784.6 million to resolve allegations that Wyeth knowingly reported to the government false and fraudulent prices on two of its proton pump inhibitor (PPI) drugs, Protonix (pantoprazole) Oral and Protonix IV. 28 April 2016
The landscape of patent litigation related to Abbreviated New Drug Applications (ANDAs) submitted to the Food and Drug Administration under the Hatch-Waxman Act is reviewed by Lex Machina, a LexisNexis company, its second Hatch-Waxman/ANDA Report. 27 April 2016
New European Union rules to help companies win legal redress against theft or misuse of their trade secrets were voted by Parliament today (April 14). 14 April 2016
The USA’s Physicians Payment Sunshine Act, proposed in 2010 and started in 2013, was created to make the financial relationship between health care providers and the pharmaceutical industry more transparent. 14 April 2016
According to media reports this morning, the US Senate Committee on Aging may soon start contempt proceedings against Canadian drugmaker Valeant Pharmaceuticals International's (TSX: VRX) Michael Pearson. 11 April 2016
South Korean drug developer Samsung Bioepis is mounting a legal challenge to patents held by US pharma AbbVie on Humira (adalimumab) for rheumatoid arthritis – the world’s best-selling drug. 5 April 2016
The move to limit tax inversions by the US government has wiped $20 billion off the share price of Ireland-incorporated Allergan, which broadly equates to the tax benefit arising from US pharma giant Pfizer merging with Allergan. 5 April 2016
MorphoSys has filed a complaint at the US District Court of Delaware against Genmab and its collaboration partner Janssen Biotech, for patent infringement under US patent no 8,263,746 based on activities relating to manufacture, use and sale of Darzalex (daratumumab) in the USA. 5 April 2016