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India’s Sun Pharma has been blocked in its efforts to launch its JAK inhibitor Leqselvi (deuruxolitinib) in the USA. 6 November 2024
article
The European Union's antitrust enforcer hit Israeli drugmaker Teva Pharmaceutical Industries (NYSE: TEVA) with a 463 million-euro ($502 million) fine Thursday for launching a smear campaign against a rival multiple sclerosis drug and misusing the patent system to thwart the competitor's attempt to entering the market. 31 October 2024
Biotechnology
UK pharma major GSK has sued USA-based Moderna this week, accusing the latter of violating patents protecting GSK’s COVID-19 vaccine. 16 October 2024
Generics
Two US units of Israel’s Teva Pharmaceutical Industries have agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA), the US Department of Justice (DoJ) announced yesterday. 11 October 2024
Pharmaceutical
GSK has reached a settlement with 10 plaintiff firms, resolving 93% of the Zantac (ranitidine) product liability cases it faced in state courts across the USA. 10 October 2024
Pharmaceutical
Cardiopulmonary diseases specialist Liquidia Corporation closed Monday’s trading 11% higher following a favorable court ruling. 8 October 2024
Generics
Novo Nordisk has reached a settlement with Mylan Pharmaceuticals, now part of Viatris, putting an end to a US patent lawsuit over blockbuster diabetes treatment Ozempic (semaglutide). 8 October 2024
Pharmaceutical
Texas Attorney General Ken Paxton has filed a lawsuit against major pharmaceutical companies, including Eli Lilly (NYSE: LLY), alleging a conspiracy to artificially inflate the prices of insulin by up to 1,000%. 7 October 2024
Biotechnology
Bristol Myers Squibb has scored a major legal victory as a judge in New York dismissed a $6.4 billion lawsuit related to its acquisition of cancer company Celgene. 5 October 2024
Pharmaceutical
The US Department of Health and Human Services (HHS) has released final guidance for the second cycle of Medicare drug price negotiations. 3 October 2024
Pharmaceutical
Texas-based Cassava Sciences was trading 13% lower in Friday’s pre-market trading. 27 September 2024
Pharmaceutical
The Pharmaceutical Research and Manufacturers of America (PhRMA) is continuing its legal challenge against the US government’s drug pricing reforms. 24 September 2024
Pharmaceutical
On Friday, the USA’s Federal Trade Commission (FTC) brought action against the three largest prescription drug benefit managers (PBMs) - Caremark Rx, Express Scripts (ESI), and OptumRx 23 September 2024
Pharmaceutical
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
Generics
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
Generics
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
Generics
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
Biosimilars
Regeneron Pharmaceuticals has filed a lawsuit against Sandoz, alleging that its biosimilar to Eylea (aflibercept) infringes certain patents. 29 August 2024
Pharmaceutical
Ireland-headquartered Avadel Pharmaceuticals has updated on litigation with USA-based Jazz Pharmaceuticals. 29 August 2024
Pharmaceutical
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
Pharmaceutical
US drug majors Merck & Co) and Johnson & Johnson (NYSE: JNJ) and its subsidiary Centocor Ortho Biotech Inc have reached finally agreement to amend the distribution rights to Remicade (infliximab) and follow-on drug Simponi (golimumab), which treat chronic inflammatory diseases such as rheumatoid arthritis. 18 April 2011
Pharmaceutical
The World Health Organization announced yesterday that, after a week of negotiations continued through Friday night and into Saturday morning, an open-ended working-group meeting of member states successfully agreed upon a Framework that ensures that, in a pandemic, influenza virus samples will be shared with partners who need the information to take steps to protect public health. 18 April 2011
Pharmaceutical
US drugmaker Forest Laboratories (NYSE: FRX) says that Howard Solomon, its chairman, chief executive and president, will challenge a potential action by the Office of the Inspector General, Department of Health and Human Services (HHS-OIG), to exclude him from participation in federal health care programs, of which he was notified this week. Mr. Solomon was notified yesterday of the potential action in a letter from HHS-OIG. 15 April 2011
Generics
USA's GPhA calls on FDA to support Supreme Court review of 'case that threatens generic competition'
The USA's Generic Pharmaceutical Association (GPhA) has written a letter to Food and Drug Administration Commissioner Margaret Hamburg urging the agency to support Supreme Court review of Caraco Pharm Labs (CPD:US) versus Danish insulin giant Novo Nordisk A/S (NVO: N). 15 April 2011
Pharmaceutical
The UK government will introduce additional controls on the export to the USA of drugs used in lethal injections and is calling on the European Union to follow its lead. The necessary order to extend the controls will be laid before Parliament in the coming days. 15 April 2011
Pharmaceutical
In what is set to be a series of pharmaceutical industry prosecution, US health care giant Johnson & Johnson (NYSE: JNJ) has agreed to pay a $21.4 million criminal penalty as part of a deferred prosecution agreement with the US Department of Justice to resolve improper payments by J&J subsidiaries to government officials in Greece, Poland and Romania in violation of the Foreign Corrupt Practices Act (FCPA), the DOJ's Criminal Division announced on Friday. The agreement also resolves kickbacks paid to the former government of Iraq under the United Nations Oil for Food Program. 11 April 2011
Generics
US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) last Friday confirmed that its subsidiary, Watson Laboratories, had filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to market moxifloxacin hydrochloride ophthalmic Solution USP, 0.5%, a generic version of Alcon Vigamox, an antibiotic solution that is indicated for the treatment of bacterial conjunctivitis. 11 April 2011
Pharmaceutical
In the vast majority of circumstances, doctors act based on their clinical judgment and other factors, not based on liability concerns, according to a report released by US consumer advocacy Public Citizen. Common claims about 'defensive medicine,' a term for doctors performing unnecessary tests and procedures due to the fear of litigation, are wildly overblown, it claims. 1 April 2011
Pharmaceutical
The US Supreme Court has ruled that California county Santa Clara cannot sue a group of leading drugmakers, including US majors Pfizer (NYSE: PFE), Merck & Co (NYSE: MRK) and Bristol-Myers Squibb (NYSE: BMY), as well as US subsidiaries of UK-based AstraZeneca (LSE: AZN) and GlaxoSmithKline, France's Sanofi-Aventis (Euronext: SAN), Germany's Bayer (BAY: DE) and Japan's Takeda Pharmaceuticals (TSE: 4502), for not extending pricing agreements made with the federal government to other hospital operators that receive federal funds. 31 March 2011
Pharmaceutical
Following a positive advisory panel earlier this year, the European Commission has granted marketing authorization for Trobalt (retigabine) as an adjunctive (add-on) treatment of partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalization in adults aged 18 years and above with epilepsy. 31 March 2011
Pharmaceutical
Sanofi-Aventis (Euronext: SAN) says that the registration statement relating to the Contingent Value Rights (CVRs) offered to Genzyme shareholders as part of the French drug major's revised agreement to acquire US biotech firm Genzyme (The Pharma Letters passim) has been declared effective by the US Securities and Exchange Commission. 30 March 2011
Pharmaceutical
UK and US government tax authorities have agreed to the terms of an Advance Pricing Agreement regarding transfer pricing arrangements for Anglo-Swedish drug major AstraZeneca's (LSE: AZN) US business for the 13-year period from 2002 to the end of 2014, which will help increase the firm's earnings this year. 28 March 2011
Pharmaceutical
Federal US prosecutors in the criminal case against Lauren Stevens, the indicted former in-house counsel of UK drug giant GlaxoSmithKline (LSE: GSK) received a double dose of bad news last week. First the judge ruled against the government in saying that Ms Stevens can claim an advice-of-counsel defense to the charges against her. Then the judge dismissed the case without prejudice. 28 March 2011
Pharmaceutical
The US Federal Trade Commission has withdraw its appeal Laboratory Corporation of America's (NYSE: LH) 2010 $57.5 million acquisition of Westcliff Medical Laboratories (The Pharma Letter December 3, 2010). Although LabCorp consummated the acquisition in June 2010, the FTC was seeking the federal court injunction to prevent LabCorp from integrating the companies pending the outcome of administrative litigation. The FTC also has withdrawn the matter from administrative adjudication - a step that stops the trial proceedings, but does not conclude the case. 28 March 2011
Generics
A recently conducted a survey in the USA on drug switching, which occurs when a patient from the drug originally prescribed by his or her physician is switched to an entirely different chemical entity, revealed that more than three-quarters of doctors believe that switching is occuring without their consent. 23 March 2011
Pharmaceutical
Today marks the launch in the UK of German drug major Bayer's (BAY: DE) Levitra (vardenafil) orodispersible tablet, the first erectile dysfunction treatment available as an orodispersible tablet. 22 March 2011
Biotechnology
Canadian developer of RNA interference (RNAi) therapeutics Tekmira Pharmaceuticals (Nasdaq: TKMR) has filed a complaint against USA-based Alnylam Pharmaceuticals (Nasdaq: ALNY) for misappropriation and misuse of trade secrets, know-how and other confidential information, unfair and deceptive trade practices, unjust enrichment, unfair competition and false advertising. 21 March 2011
Pharmaceutical
The US Food and Drug Administration says that a consent decree of permanent injunction has been filed against McNeil-PPC - unit of health care giant Johnson & Johnson (NYSE: JNJ) - and two of its officers for failing to comply with current good manufacturing practice requirements as required by federal law relating to numerous recalls of the firm's over-the-counter medicines that last year cost J&J around $900 million in lost sales. 11 March 2011
Generics
In a long-running legal battle, the US Supreme Court has rejected a challenge to a 1997 settlement in which German drug major Bayer AG (BAY: DE) paid Barr Pharmaceuticals, now a subsidiary of Israel's Teva Pharmaceutical Industries (Nasdaq: TEVA), to not market a generic version of its antibiotic Cipro (ciprofloxacin). 8 March 2011
Pharmaceutical
US drug manufacturer Forest Pharmaceuticals has been sentenced by US District Judge Nancy Gertner to pay a criminal fine of $150 million and forfeit assets of $14 million following the company's guilty plea in November 2010 to one felony count of obstructing justice, one misdemeanor count of distributing an unapproved new drug in interstate commerce and one misdemeanor count of distributing a misbranded drug in interstate commerce, the Justice Department announced. 4 March 2011
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