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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
Indian drugmaker Lupin, together with its US subsidiary, Lupin Pharmaceuticals, says it has settled all ongoing litigation over the sedative Lunesta (eszopiclone) tablets, thereby dismissing a patent suit brought by the drug's manufacturer, Japan's Dainippon Sumitomo Pharma's US subsidiary Sunovion Pharmaceuticals. 5 January 2011
Generics
Privately-held Amphastar Pharmaceuticals has filed with the US District Court for the District of Columbia an Amended Complaint for Declaratory and Injunctive Relief against the US Food and Drug Administration in company's continuing battle to win approval of the its long-pending Abbreviated New Drug Application for a generic version of French drug major Sanofi-Aventis (Euronext: SAN) blockbuster anti-coagulant drug Lovenox (enoxaparin sodium injection), which generated sales of $4.57 billion for the latter firm in 2009. 5 January 2011
Pharmaceutical
Toronto, Canada-based Transition Therapeutics (TSX: TTH) has agreed to modify its collaboration with Irish firm Elan agreement for the development and commercialization of the Alzheimer's disease drug candidate ELND005. 4 January 2011
Generics
Generic drug makers which include the likes of Mylan (Nasdaq: MYL) and Watson Pharmaceuticals (NYSE: WPI) have been on a bumpy ride lately, comments www.stockcall.com, an on-line South Africa-based research and analysis service. With the recent and coming expiry of many lucrative brand name drug patents, generic makers have been able to produce lower cost versions of popular medicine. With products such as Eli Lilly's cancer drug Gemzar (gemcitabine), or Pfizer's cholesterol lowerer Lipitor (atorvastatin) now or soon to be available in generic versions, companies in the industry look well positioned moving forward. 4 January 2011
Pharmaceutical
Dey Pharma, a subsidiary of US generic drugs maker Mylan (Nasdaq: MYL) says that it has settled a law suit brought against it by the US Department of Justice in September 2006 relating to Medicare and Medicaid reimbursements paid by the federal government to pharmacists and other health care providers. In exchange for a release of claims, Dey has agreed to pay $280 million. 22 December 2010
Generics
Japan's largest drugmaker, Takeda Pharmaceutical (TYO: 4502), and its US subsidiary have completed settlements with all defendants in patent litigation brought against the companies in response to their Abbreviated New Drug Applications for generic Actos (pioglitazone HCl), ACTOplus met (pioglitazone HCl and metformin HCl) and duetact (pioglitazone HCl and glimepiride). Takeda filed the law suits to enforce several patents that expire in 2016 relating to these antidiabetic drugs. 22 December 2010
Pharmaceutical
The USA's pharmaceutical industry has now become the biggest defrauder of the federal government, as determined by payments it has made for violations of the False Claims Act (FCA), surpassing the defense industry, which had long been the leader, according to a new study released last week by consumer advocacy group Public Citizen. The study found that pharmaceutical cases accounted for at least 25% of all federal FCA payouts over the past decade, compared with 11% by the defense industry. 20 December 2010
Generics
US generics major Mylan (Nasdaq: MYL) has confirmed that, along with its subsidiary Mylan Pharmaceuticals, it been sued by Japanese drugmaker Shionogi's (TKO: 4507) US unit and CIMA Labs (which provide the drug delivery technology) in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for a copy version of their Orapred ODT (prednisolone sodium phosphate) orally disintegrating tablets, 10mg, 15mg and 30mg. The product is indicated as an anti-inflammatory or immunosuppressive agent for the treatment of certain endocrine conditions and for palliation of certain neoplastic conditions. 20 December 2010
Pharmaceutical
Dublin, Ireland-based drugmaker Elan (NYSE: ELN) says that it has finalized the agreement-in-principle with the US Attorney's Office for the District of Massachusetts to resolve all aspects of the Department of Justice's investigation of sales and marketing practices for Zonegran (zonisamide), an anti-epileptic prescription medicine that Elan divested to Japan's Eisai (TYO: 4523) in 2004. In a separate civil settlement, Eisai's US subsidiary will pay $11 million to resolve civil liability for off-label marketing of Zonegran. 17 December 2010
Pharmaceutical
Germany's Evotec AG (FSE: EVT), via its subsidiary Develogen AG, has entered into a license and collaboration agreement with Anglo-Swedish drug major AstraZeneca's (LSE: AZN) USA-based biologics subsidiary MedImmune in the diabetes therapeutic area, with a particular focus on the regeneration of insulin producing beta cells. 16 December 2010
Generics
The USA's highest court has agreed to hear appeals by Israel's Teva Pharmaceutical Industries (Nasdaq: TEVA), USA-based Mylan's (Nasdaq: MYL) UDL Laboratories and privately-held Icelandic firm Actavis that would decide whether generic drug companies could be sued under state law over allegations they had failed to provide adequate label warnings about potential side effects, according to various US news services, including Bloomberg and Yahoo. 13 December 2010
Generics
The Federal Court of Appeal in Canada has released a unanimous decision upholding some important safeguards in Canada's Intellectual Property (IP) Regime which are crucial to facilitating patient access to new medicines and to building a stronger, internationally competitive life sciences industry in Canada. 13 December 2010
Pharmaceutical
The Global Fund to Fight AIDS, Tuberculosis and Malaria will invite major international funders of drug supplies to developing countries, technical and law enforcement agencies and implementers of health programs to intensify joint efforts to prevent theft of medical drugs. 13 December 2010
Pharmaceutical
US health care major Abbott Laboratories (NYSE: ABT), B Braun Medical (a US subsidiary of Germany's B Braun Melsungen AG) and Roxane Laboratories (the generics unit of independent German drugmaker Boehringer Ingelheim) and affiliated entities have agreed to pay $421 million to settle False Claims Act allegations, the US Department of Justice announced yesterday. 8 December 2010
Pharmaceutical
Pfizer (NYSE: PFE), the world's largest drugmaker, late last night said that its board of directors has elected 57-year old Ian Read, currently head of the company's global biopharmaceutical operations, as president, chief executive and director to succeed Jeffrey Kindler, who somewhat suddenly and unexpectedly announced that he has retired from the firm. 6 December 2010
Pharmaceutical
Ireland-headquartered specialty pharma firm Shire plc (LSE: SHP) has filed a lawsuit in the US District Court for the Northern District of California against Impax Laboratories (Nasdaq: IPXL) and Watson Pharmaceuticals (NYSE: WPI) for the infringement of US Patent numbers. 5,854,290, 6,287,599 and 6,811,794, covering the firm's attention-deficit hyperactivity disorder (ADHD) drug Intuniv (guanfacine HCl) extended release tablets. 6 December 2010
Generics
The European Commission has confirmed that, on November 30, Commission officials carried out unannounced inspections at the premises of a limited number of companies active in the pharmaceutical sector in several European Union member states. 3 December 2010
Generics
US drugmaker Momenta Pharmaceuticals (Nasdaq: MNTA) announced that it has sued Israeli generics major Teva Pharmaceutical Industries in the US District Court for the District of Massachusetts for infringement of two Momenta patents. 3 December 2010
Pharmaceutical
As part of its ongoing efforts to ensure competition in US health care markets, the Federal Trade Commission has challenged Laboratory Corporation of America's (NYSE: LH) $57.5 million acquisition of rival clinical laboratory testing company Westcliff Medical Laboratories, which was completed in June this year, alleging that the transaction would harm competition in Southern California. 3 December 2010
Generics
Recent judicial setbacks for the USA's Federal Trade Commission) in actions challenging patent settlement agreements (often called 'pay-for-delay' or 'reverse payment' deals) and opposition from both Republicans and Democrats to the inclusion of the Preserve Access to Affordable Generics Act (S 369) in the Fiscal Year 2011 Financial Services and General Government Appropriations Bill (S 3677) may cause the FTC to consider 'Plan C' to address such agreements, according to the agency's Commissioner J Thomas Rosch. 1 December 2010
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