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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
Biotechnology
A US District Court has entered final judgment in favor of UK pharma giant GlaxoSmithKline (LSE: GSK) in a patent infringement case involving Arzerra (ofatumumab) brought against GSK by Genentech, a subsidiary of Swiss major Roche (ROG: SIX), and the USA's Biogen Idec (Nasdaq: BIIB). 18 November 2011
Generics
Sergei Lisovsky, a well-known Russian senator and public figure, has put forward an initiative to make controversial amendments in the Russian Federal Law 'On the Circulation of pharmaceutical drugs in Russia,' the basic law in the Russian pharmaceutical market, which may negatively affect the Russian business of multinational pharmaceutical producers. 16 November 2011
Generics
In the USA, there have been rumors for several weeks that, once the ball gets rolling in Congress with legislation to reauthorize the various user fee statutes (eg, the Prescription Drug User Fee Act and the Medical Device User Fee and Modernization Act) and other statutory provisions (eg, the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act), along with legislation to create new law (eg, the Generic Drug User Fee Act), there might be a push to open up and amend the Hatch-Waxman Amendments, comments Kurt Karst on law firm Hyman, Phelps & McNamara's FDA Law Blog. 8 November 2011
Generics
US Congressman Charles Bass (Republican, New Hampshire) has introduced bipartisan legislation in the House of Representatives that will encourage and incentivize states to use cost-saving generic prescription drugs in the Medicaid program, saving the program millions of dollars every year. Representatives Jo Ann Emerson (Republican, Missouri) and Peter Welch (Democrat, Vermont) are original cosponsors of Rep Bass' bill, the Affordable Medicines Utilization Act of 2011 (HR 3342). 7 November 2011
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) said yesterday that it has reached an agreement in principle with the US government to finalize a number of ongoing Federal investigations. The final settlement totals $3 billion and is due to be paid in 2012. This is covered by existing provisions and will be funded through existing cash resources, as GSK announced with its fourth-quarter 2010 results that it was making provisions for a record-breaking 2.2 billion ($3.5 billion) relating to the US investigations (The Pharma Letter January 18). 4 November 2011
Biotechnology
The UK's Supreme Court yesterday gave guidance on the patentability of gene sequence inventions, with its judgment in Human Genome Sciences (Nasdaq: HGSI) versus Eli Lilly (NYSE: LLY), the first patent case that it has considered. 3 November 2011
Generics
The European Commission revealed last Friday that it has opened an antitrust investigation, on its own initiative, to assess whether contractual arrangements between US drug major Johnson & Johnson (NYSE: JNJ) and the generic branches of the Switzerland-based Novartis (NOVN: VX) may have had the object or effect of hindering the entry on to the market of generic versions of the chronic pain drug fentanyl in the Netherlands. 24 October 2011
Biotechnology
Europe's largest biotech company, Actelion (SIX: ATLN), announced this morning that, the Superior Court of the State of California, USA, has granted its motion for a new trial on compensatory damages awarded to Japanese drugmaker Asahi Kasei Pharma unless the latter consents, by November 10, 2011, to a reduction of the jury award by a further $99.2 million, thus respecting - in part - a request that Asahi make an election between damages for alleged lost profits or alleged development costs relating to the now dropped development of the rho kinase inhibitor fasudil. 24 October 2011
Generics
US generic drugmaker Mylan (Nasdaq: MYL) said yesterday that it, along with Famy Care, has entered into a settlement agreement with Ireland-headquartered Warner Chilcott (Nasdaq: WCRX) resolving litigation related to the oral contraceptive Femcon Fe Chewable Tablets, known generically as norethindrone and ethinyl estradiol Tablets USP 0.4mg/0.035mg and ferrous fumarate tablets USP (Chewable), 75mg (28-Day Regimen). 19 October 2011
Pharmaceutical
US Senator Herb Kohl (Democrat, Wisconsin), Chairman of the US Senate Special Committee on Aging, last week introduced legislation seeking a wide range of drug cost cuts, including a proposal to require drug manufacturers to provide Medicare Part B with the same discounts Medicaid receives, saying his: 'Prescription Drug Cost Reduction Act provides a number of opportunities to significantly reduce the cost of health care without pushing those costs onto consumers or limiting access to care.' 17 October 2011
Pharmaceutical
USA-based PharmAthene (NYSE Amex: PIP) says it has filed its legal brief in response to one-time merger partner SIGA Technologies' (Nasdaq: SIG) motion for reargument relating to profit sharing on a potential small pox drug, the sales of which could reach $400 million a year. 14 October 2011
Pharmaceutical
US drugmaker Onyx Pharmaceuticals (Nasdaq: ONXX) and German pharma major Bayer HealthCare, a unit of Bayer AG (BAY: DE), have resolved a long-running argument and have restructured their partnership for the global development and marketing of their liver and kidney cancer drug Nexavar (sorafenib) and entered into a new agreement related to regorafenib, a late-stage oncology compound. The news pushed Onyx' shares 6.6% higher to $34 in pre-market trading yesterday. 13 October 2011
Generics
Israel-based Teva Pharmaceutical Industries (Nasdaq: TEVA) says that the US Federal Trade Commission has accepted the proposed consent order in connection with the pending $6.8 billion acquisition of US biotech firm Cephalon (Nasdaq: CEPH) by Teva, which outbid Canada's Valeant Pharmaceuticals for the company (The Pharma Letter March 3), and granted early termination of the Hart Scott Rodino waiting period. 10 October 2011
Generics
The US District of Massachusetts has granted a request by Momenta Pharmaceuticals (Nasdaq: MNTA) and partner Sandoz (the generics unit of Swiss drug major Novartis; NOVN: VX) for a temporary restraining order (TRO) preventing Watson Pharmaceuticals (NYSE: WPI) and Amphastar Pharmaceuticals from marketing or selling Amphastar's enoxaparin sodium injection product, a generic equivalent to French major Sanofi's (Euronext: SAN) Lovenox enoxaparin). 10 October 2011
Pharmaceutical
Scios, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), has pleaded guilty tto a misdemeanor violation of the Food, Drug and Cosmetic Act (FDCA) for introducing into interstate commerce its heart failure drug, Natrecor (nesiritide), for a use that was not approved by the Food and Drug Administration the Justice Department announced. 7 October 2011
Generics
In further patent settlements in the USA, Anglo-Swedish drug major AstraZeneca (LSE: AZN) has now announced agreements with two further companies - Accord Healthcare and its Indian parent company Intas Pharmaceuticals - relating to Accord's proposed generic copy of its blockbuster antipsychotic drug Seroquel XR (quetiapine, extended release). 6 October 2011
Pharmaceutical
According to a multi-count whistleblower action in the USA, alleging violations of federal and state False Claims Acts (FCA), more than a dozen top brand-name prescription drug manufacturers in the USA allegedly underpaid rebates to state Medicaid programs over the past seven years. On October 3, the US District Court for the Eastern District of Pennsylvania notified the parties that the whistleblower's Motion for Leave to File the Fourth Amended Complaint was granted. 6 October 2011
Pharmaceutical
US drugs giant Merck & Co (NYSE: MRK) says that a federal court jury in New York found in its favor in the Secrest v Merck case, rejecting the claim of a Florida woman who blamed her dental and jaw-related problems on her use of the firm's bisphosphonates osteoporosis drug Fosamax (alendronate). 4 October 2011
Pharmaceutical
USA-based PharmAthene (NYSE Amex: PIP) last week won a significant decision in its litigation against onetime merger partner candidate SIGA Technologies (Nasdaq: SIG) in the Delaware Court of Chancery, meaning that SIGA must share the profit from sales of a smallpox drug that may total more than $400 million. 25 September 2011
Generics
US generic drugs giant Mylan (Nasdaq: MYL) says that it has entered into a settlement and license agreement with Swiss pharma major Roche (ROG: SIX), resolving litigation related to Xeloda (capecitabine) tablets, 150mg and 500mg, USP, an orally administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. 21 September 2011
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