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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 giant Merck & Co sales that global sales in the first-quarter of 2012 increased 1% to $11.7 billion, shy of analysts' consensus expectations of $11.82 billion, driven by growth of 3% in pharmaceuticals (6% excluding the Impact of the J&J arbitration settlement), 8% in animal health and 7% in consumer care. 30 April 2012
Generics
Swiss drug major Novartis (NOVN: VX) has reported a sharp fall in first-quarter 2012 profits, due in part to manufacturing problems at a US plant and falling sales at its generic unit Sandoz and its vaccines and Diagnostics business, as well as a strong US dollar. 24 April 2012
Pharmaceutical
US drug giant Merck & Co (NYSE: MRK) was sentenced by US District Court Judge Patti Saris in Boston to pay a criminal fine in the amount of $321,636,000 in connection with its guilty plea related to its promotion and marketing of the painkiller Vioxx (rofecoxib), the Justice Department announced yesterday. In December 2011, Merck pleaded guilty to violating the Food, Drug, and Cosmetic Act (FDCA) for introducing a misbranded drug, Vioxx (which was withdrawn from the market in 2004 because of serious side effects), into interstate commerce. 20 April 2012
Biotechnology
US Senators Richard Burr (Republican, North Carolina) and Tom Coburn (Republican, Oklahoma) this week introduced the Promoting Accountability, Transparency, Innovation, Efficiency and Timeliness at FDA (PATIENTS' FDA) Act, a bill to help make sure that the Food and Drug Administration fulfills its mission to ensure that patients have access to cutting-edge, life-saving drugs and devices as quickly as possible. 19 April 2012
Pharmaceutical
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) has welcomed the bipartisan support for the BPCA and PREA Reauthorization Act of 2012 in the House of Representatives and for the Senate's Better Pharmaceuticals and Devices for Children Act of 2012, both of which would permanently reauthorize the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). 19 April 2012
Generics
The US Supreme Court yesterday reversed the US Court of Appeals for the Federal Circuit's April 2010 decision that dismissed Caraco Pharmaceutical's claim to change Danish insulin giant Novo Nordisk's (NOV: N) patent submissions regarding the combination use of Prandin (repaglinide) and metformin for the treatment of type 2 diabetes. 18 April 2012
Pharmaceutical
In the USA, the Arkansas jury found that the Janssen unit of US health care giant Johnson & Johnson (NYSE: JNJ) committed more than 238,000 violations of the state's Medicaid fraud laws by illegally marketing Risperdal (risperidone) for almost four-year period starting in 2002, and imposed a penalty of around $1.1 billion, according to US media reports. The state, which is also seeking damages in the case, had sought more than $1.2 billion in penalties. 12 April 2012
Generics
ViroPharma I (Nasdaq: VPHM) saw its shares plunge 19% to $23.25 yesterday after it announced that the US Food and Drug Administration had denied the citizen petition the company filed on March 17, 2006 related to the FDA's proposed in vitro method for determining bioequivalence of Abbreviated New Drug Applications referencing its antibiotic Vancocin (vancomycin hydrochloride, USP) Capsules. 11 April 2012
Generics
Israel-based Teva Pharmaceutical Industries (Nasdaq: TEVA) said on April 5 that the US Food and Drug Administration has decided that its wholly owned subsidiary, Teva Pharmaceuticals USA, is sole first-to-file for both Orange Book patents listed for Provigil (modafinil), a drug for the treatment of narcolepsy, and therefore Teva's ANDA alone is entitled to 180-day exclusivity. 9 April 2012
Generics
US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) has confirmed that its subsidiary, Watson Laboratories, has filed Abbreviated New Drug Applications with the US Food and Drug Administration seeking approval to market bimatoprost ophthalmic solution, 0.01% and bimatoprost ophthalmic solution, 0.03%. 5 April 2012
Generics
Polish legislation authorizing the placing on the market of foreign medicinal products lacking authorization by the European Medicines Agency which are cheaper than, but similar to, those already authorized is contrary to European Union law, according to the European Court of Justice. 2 April 2012
Biotechnology
US Representative Mike Rogers (Republican, Michigan) this week introduced bipartisan legislation with Representatives Anna Eshoo (Democrat, California) and Ed Markey (Democrat, Massachusetts) that creates a permanent structure for strengthening testing of pediatric drugs and improving their safety. 29 March 2012
Generics
Horizon Pharma (Nasdaq: HZNP) has filed a patent infringement lawsuit in the US District Court for the District of Delaware against fellow USA-based Par Pharmaceutical (NYSE: PRX) and related to an Abbreviated New Drug Application that Par filed with the Food and Drug Administration to market a generic version of Duexis (ibuprofen and famotidine) tablets. 29 March 2012
Biotechnology
UK pharma giant GlaxoSmithKline (LSE: GSK) has agreed a settlement with Genentech, a unit of Roche (ROG: SIX), and City of Hope (a California not-for-profit organization) concerning two US patents that relate to recombinant antibody production for ofatumumab, which is being commercialized in the USA and Europe by GSK under the trade name Arzerra for the treatment of chronic lymphocytic leukemia. 28 March 2012
Generics
Health-related consumer groups Health Action International (HAI) Europe, Oxfam, Medecins Sans Frontieres (MSF) and the Trans Atlantic Consumer Dialogue (TACD) have issued a call for European Union parliamentarians to condemn the Anti-Counterfeiting Trade Agreement ( ACTA) independently of the European Court of Justice (ECJ) referral. 27 March 2012
Generics
In another setback for Anglo-Swedish drug major AstraZeneca in its fight to delay generic competition for its blockbuster antipsychotic Seroquel (quetiapine), the US District Court for the District of Columbia late last Friday issued an opinion and order in the law suit against the US Food and Drug Administration regarding final marketing approval of generic quetiapine. 26 March 2012
Pharmaceutical
In another setback regarding intellectual property on its blockbuster antipsychotic drug, AstraZeneca today announced that the High Court in the UK has rendered a negative opinion on the formulation patent protecting Seroquel XR (quetiapine fumarate) prolonged-release tablets currently pending in the UK court. 23 March 2012
Biotechnology
In recent years, smaller biotechnology companies have received less funding from venture capitalists than in years past. According to the Biotechnology Industry Organization (BIO), roughly 61% of venture capitalists cite the challenging approval process of the Food and Drug Administration as having the largest impact on their investment decisions, noted a report by Five Star Equities. 22 March 2012
Biotechnology
New legislation overhauling the Australian patent system will encourage medical research and bring Australia into line with intellectual property systems in other OECD countries, says Medicines Australia chief executive Brendan Shaw. 20 March 2012
Generics
United Therapeutics (Nasdaq: UTHR) says that it has filed a law suit in the US District Court for the District of New Jersey against Sandoz, the generic drug unit of Swiss drug major Novartis (NOVN: VX), for infringement of US patents relating to its pulmonary arterial hypertension drug Remodulin (treprostinil) injection. 16 March 2012
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