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Generics
The Medicines Company (Nasdaq: MDCO) says that it has settled the law suits filed by company in the US District Court for the District of Delaware relating to the Abbreviated New Drug Application filed by APP Pharmaceuticals, a unit of Fresenius Kabi, for a generic version of the anticoagulant Angiomax (bivalirudin for injection). 24 January 2012
Generics
US generic drugmaker Perrigo (Nasdaq: PRGO;TASE) says that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration for azelastine hydrochloride nasal spray (0.15%) and has notified Meda Pharmaceuticals, the US subsidiary of Sweden's Meda (OMX: MEDA A), the owner of the New Drug Application for the branded version, Astepro, of its filing. The ANDA filing involved contributions from both Perrigo and Impax Laboratories (Nasdaq: IPXL), which will share costs and benefits of this project. 24 January 2012
Pharmaceutical
2012 will be a critical year for the pharmaceutical industry, as drugmakers struggle with record patent expirations, disappointing results of expensive clinical trials and ongoing regulatory challenges against an already challenging economic backdrop, observes Fitch Ratings. 23 January 2012
Pharmaceutical
US drug giant Merck & Co (NYSE: MRK) revealed yesterday that it has entered into an agreement to resolve all class action related to its COX-2 inhibitor pain killer Vioxx (rofecoxib) in Canada amounting to up to C$36.9 million ($36.0 million). The agreement was signed by Merck and plaintiffs' representatives and is pending approval by courts in Canada's provinces. 20 January 2012
Pharmaceutical
US pharmacy health care provider CVS Caremark (NYSE: CVS) will pay $5 million to settle Federal Trade Commission charges that it misrepresented the prices of certain Medicare Part D prescription drugs - including drugs used to treat breast cancer symptoms and epilepsy - at CVS and Walgreens pharmacies. 15 January 2012
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) says it disagrees with the recent court ruling in favor of ANMAT (the Argentinean National Administration of Medicines, Food and Medical Technology) on the fine issued to GSK regarding the administrative conduct of the COMPAS (Clinical Otitis Media and PneumoniA Study) study in Mendoza, Argentina. 12 January 2012
Generics
US generic drugmaker Mylan (Nasdaq: MYL) has confirmed that it has been sued by Takeda Pharmaceutical (TYO: 4502), Watson Pharmaceuticals (NYSE: WPI) and privately-held Andrx Labs in connection with the filing of an Abbreviated New Drug Application with the US Food and Drug Administration for pioglitazone hydrochloride and extended-release metformin HCL tablets, 15mg/1,000mg and 30mg/1,000 mg. This product is the generic version of Takeda's Actoplus Met XR, which is indicated to improve glycemic control in adults with type 2 diabetes mellitus. 9 January 2012
Pharmaceutical
The US Food and Drug Administration says that a recent clinical trial with Doribax (doripenem) being conducted by health care giant Johnson & Johnson's (NYSE: JNJ) Janssen subsidiary was stopped early because of significant safety concerns. 9 January 2012
Biotechnology
Regeneron Pharmaceuticals (Nasdaq: REGN) says it has entered into a non-exclusive license and partial settlement agreement with Genentech, part of Swiss drug major Roche (SIX: ROG) relating to US ophthalmic sales of Eylea (aflibercept) Injection. 4 January 2012
Pharmaceutical
Japan's largest drugmaker, Takeda Pharmaceuticals (TYO: 4502) says that it has reached a mutual agreement with US drug giant Merck & Co (NYSE: MRK), which is known as MSD outside the USA and Canada, to terminate their co-promotion agreement for Daxas (roflumilast) in certain European countries and Canada as of December 31, 2011. 3 January 2012
Generics
India's largest drugmaker Ranbaxy Laboratories (RANB: BO), which is 64% owned by Japan's Daiichi Sankyo, has signed a consent decree with the US Food and Drug Administration, committing to further strengthen procedures and policies to ensure data integrity and to comply with current Good Manufacturing Practices. The consent decree is subject to approval by the US District Court for the District of Maryland. 22 December 2011
Biotechnology
US neuro drug discovery firm Intellect Neurosciences (OTCBB: ILNS) says that it has filed an appeal regarding a preliminary decision of the European Patent Office (EPO) to revoke the company's ANTISENILIN monoclonal antibody platform patents. 15 December 2011
Pharmaceutical
USA-based Salix Pharmaceuticals (Nasdaq) said yesterday that it has submitted a New Drug Application to the US Food and Drug Administration for Crofelemer, a proprietary proanthocyanidin, for the proposed treatment of HIV-associated diarrhea, just as there were more revelations on its arguments with the drug's originator, California-based Napo Pharmaceuticals. By regulation, the FDA has 60 days from the date of submission to conduct a filing review to determine if the application is sufficiently complete to permit a substantive review. 15 December 2011
Pharmaceutical
The USA's Securities and Exchange Commission says it has charged a subsidiary of UK pharma giant GlaxoSmithKline (LSE: GSK) and the subsidiary's former chairman and chief executive with defrauding employees and other shareholders in the company's stock plan by buying back their stock at severely undervalued prices. 14 December 2011
article
US Senator Herb Kohl (Democrat, Wisconsin), Chairman of the Special Committee on Aging, held a hearing this week examining the widespread inappropriate use of antipsychotics among nursing home residents suffering from dementia, high costs to taxpayers and the efforts to find safe and effective alternatives. 2 December 2011
Pharmaceutical
The Court of Justice of the European Union (CJEU) yesterday handed down a landmark judgment clarifying the scope of protection afforded by Supplementary Protection Certificates (SPCs) and the circumstances under which they can be granted. The ruling answers questions referred by the Court of Appeal of England and Wales in the cases of Medeva (a company bought by Celltech that, in turn, was taken over by Belgium's UCB in 2004) and Georgetown University, USA. 25 November 2011
Pharmaceutical
US pharma giant Merck & Co (NYSE: MRK) has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx (rofecoxib), which was withdrawn from the market in September 2004, the Justice Department and the drugmaker announced yesterday. Merck shares dipped just less than 1% to $33.81, in a downturned US market. 23 November 2011
Pharmaceutical
Less than a month before the US Supreme Court is scheduled to hear Oral Argument in Caraco Pharmaceutical Laboratories versus Novo Nordisk, concerning whether the patent delisting counterclaim provisions at FDC Act Sec 505(j)(5)(C)(ii)(I), as added by the Medicare Modernization Act, may be used to correct or delete an Orange Book-listed Patent Use Code (PUC), the US District Court for the District of New Jersey granted a Motion to Dismiss a similar counterclaim in Hoffmann-La Roche vs Orchid Chemicals & Pharmaceuticals a patent infringement law suit concerning generic Boniva (ibandronate sodium) tablets, 150mg. originated by Switzerland's Roche, notes Hyman, Phelps & McNamara lawyer Kurt Karst on the firm's FDA Law Blog 22 November 2011
Pharmaceutical
Bipartisan, bicameral legislation was introduced in the USA last week by Senators Patrick Leahy (Democrat, Vermont), Chuck Grassley (Republican, Iowa), Michael Bennet (Democrat, Colorado), and Richard Blumenthal (Democrat, Connecticut) and US Representatives Patrick Meehan (Republican, Pennsylvania) and Linda Sanchez (Democrat, California) to increase penalties for trafficking counterfeit drugs. The legislation responds to recommendations made by the US Intellectual Property Enforcement Coordinator and the administration's Counterfeit Pharmaceutical Inter-agency Working Group. 21 November 2011
Biotechnology
Despite a final judgement issued on Friday by the Superior Court of the State of California, USA, to reduce the original verdict by nearly $170 million, Swiss biotech firm Actelion (SIX: ATLN) today confirmed its intention to appeal the verdict in the case of Japan's Asahi Kasei Pharma versus Actelion et al (case number CIV 478533. 21 November 2011
Biotechnology
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
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