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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
Generics
US subsidiaries of Israeli generics giant Teva Pharmaceutical Industries have agreed to pay the US government and the state of Illinois $27.6 million for allegedly violating the False Claims Act by making payments to induce prescriptions of an anti-psychotic drug for Medicare and Medicaid beneficiaries, the US Justice Department has announced. 12 March 2014
Pharmaceutical
Some of the USA’s largest pharmaceutical companies have cut payments to health professionals for promotional speeches about their products, according to a report from US investigative journalists ProPublica. 6 March 2014
Pharmaceutical
Swiss pharma majors Roche and Novartis colluded to exclude the cheaper cancer drug Avastin (bevacizumab), used in the treatment of the most common eyesight condition in the elderly as well as other serious sight problems, and channel demand towards the much more expensive drug Lucentis (ranibizumab), through an artificial distinction between the two products, says Italy’s anti-trust authority, the Autorita Garante della Concorrenza e del Mercato (AGCM) in an announcement made yesterday. 6 March 2014
Biotechnology
US biotech firm Amarin revealed in a Stock Exchange Commission submission that it has filed a complaint in the US District Court for the District of Delaware against Omthera Pharmaceuticals and its parent company, Anglo-Swedish drug major AstraZeneca. 5 March 2014
Generics
Ireland-headquartered generic drugmaker Actavis revealed on Friday (February 28) that French pharma giant Sanofi had filed suit on February 26, in the US District Court for the District of Delaware, seeking to prevent Actavis from commercializing its Abbreviated New Drug Application for a generic version of Multaq (dronedarone) prior to the expiry of certain US patents. 2 March 2014
Biotechnology
US biotech firm Amarin has filed with a federal court requesting it to order the US Food and Drug Administration to extend its marketing exclusivity for Vascepa (icosapent ethyl), an adjunct to diet to reduce triglyceride, for five years, according to a report from Bloomberg. 28 February 2014
Pharmaceutical
US Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius have released the annual Health Care Fraud and Abuse Control (HCFAC) Program report showing that for every dollar spent on health care-related fraud and abuse investigations through this and other programs in the last three years, the government recovered $8.10. 27 February 2014
Biosimilars
US trade group the Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF) have called on State Governor Mike Pence to sign critical legislation to create a pathway for the substitution of interchangeable biologic medicines, or biosimilars. 27 February 2014
Pharmaceutical
US drugmaker Endo Health Solutions and its subsidiary Endo Pharmaceuticals have agreed to pay $192.7 million to resolve criminal and civil liability arising from Endo’s marketing of the prescription pain drug Lidoderm (lidocaine) for uses not approved as safe and effective by the Food and Drug Administration, the Justice Department announced on Friday. 23 February 2014
Biotechnology
The USA-based AIDS Healthcare Foundation (AHF) says it has won another key legal victory late last week in a push for drug safety as well as increased government transparency. 19 February 2014
Pharmaceutical
US drugmaker Allergan (NYSE: AGN) is the subject of legal action after allegations that it paid kickbacks to induce prescriptions of its eye care drugs. 14 February 2014
Pharmaceutical
The Australian Competition and Consumer Commission revealed today that is has instituted proceedings in the Federal Court of Australia against the local subsidiary of US pharma behemoth Pfizer for alleged misuse of market power and exclusive dealing in relation to its supply of atorvastatin to pharmacies in contravention of the Competition and Consumer Act 2010. 13 February 2014
Pharmaceutical
The US Department of Justice is investigating Israel drugmaker Teva Pharmaceutical Industries’ marketing and sales practices for Parkinson’s disease drug Azilect (rasagiline) and its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate), the company has revealed in a filing with the US Securities and Exchange Commission. 11 February 2014
Biosimilars
Swiss pharma major Roche’s Indian subsidiary has sued Bangalore-based Biocon and US generics firm Mylan ), just as the companies were launching the world's first biosimilar version of Roche blockbuster breast cancer drug Herceptin (trastuzumab) in India (The Pharma Letter February 3), report the Economic Times and other media. 10 February 2014
Pharmaceutical
US pharma giant Pfizer has prevailed in protecting intellectual property for its blockbuster drug Lyrica (pregabalin), saying a panel of the Court of Appeals for the Federal Circuit has upheld the composition of matter patent covering the drug. 7 February 2014
Biotechnology
A US federal court yesterday unsealed a whistleblower/false claims law suit brought against US biotech firm Celgene, according to law firm Grant & Eisenhofer, which represents a key whistleblower. 7 February 2014
Biotechnology
US drugmaker PDL BioPharma has entered into an agreement with Genentech and its parent, Swiss drug major Roche, resolving all outstanding legal disputes between the parties relating to alleged unpaid royalties going back to 2007. 3 February 2014
Pharmaceutical
US drugmaker Forest Laboratories, together with Merz Pharma and Adamas Pharmaceuticals, has filed a law suit for infringement of patents related to its dementia and Alzheimer’s disease drug Namenda XR (memantine). 2 February 2014
Biosimilars
French drug major Sanofi says it has filed a patent infringement suit against USA pharma firm Eli Lilly in the US District Court for the District of Delaware, alleging infringement of four patents. 31 January 2014
Pharmaceutical
Though Chinese regulators are pushing ahead with a blacklisting system to combat bribery in pharmaceutical procurement, enforcement problems have undermined similar initiatives in the past, according to Policy and Regulatory Report (PaRR). 29 January 2014
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