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Pharmaceutical
US pharma behemoth Pfizer (NYSE: PFE) has launched a pre-emptive strike against generic drug manufacturer Mylan (Nasdaq; MYL) to protect its smoking cessation drug Chantix (varenicline), according to a report by The Street.Com. 2 September 2010
Biotechnology
US drug developer PDL BioPharma (Nasdaq: PDL) said yesterday that it has filed suit in a Nevada state court to compel commercial partner Swiss drug major Roche (SIX: ROG.VX) and its US subsidiary Genentech to continue paying royalties on certain Roche products that infringe upon PDL's biotechnology patents. 2 September 2010
Biotechnology
The US Federal District Court for the District of Columbia this week issued a temporary injunction on President Barack Obama's 2009 executive order that expanded federal funding for embryonic stem cell research, returning to order the previous ban enforced by the Bush administration in 2001. 26 August 2010
Pharmaceutical
In a decision that was not widely expected given ongoing liver damage concerns, a US Food and Drug Administration advisory panel yesterday voted by a narrow eight to six to back expanded use of drug major Eli Lilly's (NYSE: LLY) antidepressant Cymbalta (duloxetine). 20 August 2010
Pharmaceutical
According to a report by the UK's Financial Times, the US Department of Justice is scrutinizing payments by leading pharmaceuticals companies for hospitality, consultants, licensing agreements and charitable donations in markets around the world as part of a wide-ranging corruption probe. 13 August 2010
Generics
US drug giant Merck & Co has reported results from two pivotal Phase III studies: HCV SPRINT-2 (n=1097) and HCV RESPOND-2 (n=403) of boceprevir, an oral hepatitis C protease inhibitor, for the treatment of chronic hepatitis C. In both the studies, data indicated that addition of boceprevir to treatment with Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin, USP) (Peg/riba) significantly increased the percentage of patients who achieved sustained virologic response, compared to control groups who received Peginterferon/ribavirin plus placebo. 5 August 2010
Pharmaceutical
Michael Bennet, Democrat Senator for the US state of Colorado, is making a push to protect consumers by improving the safety and quality of US drugs. 5 August 2010
Pharmaceutical
The Russian pharmaceutical market has undergone significant changes in the past couple of years, and these changes are set to continue with the introduction of new Federal Law No. 61-FZ of April 12, 2010, On the Circulation of Pharmaceuticals, notes Aina Lavrentieva, partner, pharmaceutical practice leader at PricewaterhouseCoopers, in that country, quoted by the Moscow Times. The Law is aimed at improving legislation regulating the circulation of pharmaceuticals, taking into account the development priorities for the pharmaceutical industry in Russia. 4 August 2010
Generics
The Competition Bureau in Canada has reached an agreement with Israeli generics giant Teva Pharmaceutical Industries and the Merckle Group (carrying on business as Ratiopharm), requiring divestitures of certain assets and associated licences of certain dosage forms of acetaminophen oxycodone tablets and morphine sulfate sustained-release tablets in Canada. 3 August 2010
Pharmaceutical
Sanofi Aventis posted a strong set of second-quarter 2010 results this morning, but the company's chief executive Chris Viehbacher, unveiling the financials in Paris, remained tight-lipped about the French drug major's interest in acquiring troubled US biotechnology firm Genzyme, as has been rumoured for around a week (The Pharma Letter July 26 and 27). 29 July 2010
Generics
Commenting on US Federal Trade Commission Chairman Jon Leibowitz' testimony before the House of Representatives Committee on the Judiciary, Subcommittee on Courts and Competition Policy (The Pharma Letter July 28), the Generic Pharmaceutical Association (GPhA) described it as misguided and failing to present the whole story regarding patent settlements. 29 July 2010
Pharmaceutical
Anglo-Swedish drug major AstraZeneca has filed a Para IV patent infringement law suit against the Gujarat-based Torrent Pharmaceuticals and its US subsidiary for its alleged move to manufacture and sell a generic version of its blockbuster cholesterol-lowering drug Crestor (rosuvastatin), before its patent expiry. 29 July 2010
Pharmaceutical
US law firm Baum Hedlund, which filed the claims, says that Taiwanese hemophiliacs infected by HIV-contaminated medications have petitioned the US Supreme Court to allow their claims to proceed in California. 29 July 2010
Generics
The European Commission has addressed a Statement of Objections under European Union antitrust rules to French independent pharmaceutical company Laboratoires Servier, noting that, on a provisional view, it has evidence that Servier has provided misleading and incorrect information in reply to a request for information in the context of the pharmaceutical competition sector inquiry. 28 July 2010
Generics
The US Senate has approved a $60 billion measure to fund the troop buildup in Afghanistan after refusing to include $10 billion in state aid sought by the House to prevent an estimated 140,000 teacher layoffs, and also dropped the 'Preserve Access to Affordable Generics Act,' which is intended to curb pharmaceutical patent settlement agreements - so-called 'pay-for-delay' deals between research-based pharmaceutical companies and generic drugmakers, which the House of Representatives passed earlier by a vote of 239 to 182 (The Pharma Letter July 5). 28 July 2010
Generics
Judge Jose Linares of the US District Court for the District of New Jersey has confirmed the jury verdict in favor of independent Swiss drugmaker Nycomed and US drug behemoth Pfizer (The Pharma Letter April 26). 20 July 2010
Pharmaceutical
Last week, Irish drugmaker Elan Corp said that it has reached an agreement in principle with the US Attorney's Office for the District of Massachusetts with respect to the previously-disclosed US Department of Justice's investigation which started in 2006 of sales and marketing practices for the prescription anti-epileptic drug Zonegran (zonisamide), an that Elan divested to Japan's Eisai in 2004. 19 July 2010
Pharmaceutical
To the delight of GlaxoSmithKline, but no doubt to the surprise - even dismay - of others, US Food and Drug Administration advisors have voted to keep the UK drug giant's type 2 diabetes drug Avandia (rosiglitazone) on the market, despite suggested cardiovascular side effects, albeit with added warnings. The news saw GSK's shares edge 1.1% higher to 11.95 in early trading this morning. 15 July 2010
Pharmaceutical
Swiss drug major Novartis says that its US subsidiary, Novartis Pharmaceuticals Corp (NPC), has reached an 'amicable' end to litigation in a class action suit over gender discrimination brought by female employees, agreeing to a settlement of around $152.5 million and to spend an estimated $22.5 million on improving policies and programs to promote equality in the workplace. 15 July 2010
Pharmaceutical
In the USA, the California Supreme Court on Tuesday reinstated a potentially multi-million-dollar price-fixing law suit against 20 large pharmaceutical companies, reported the Bay City News Service. In a ruling issued in San Francisco, the court unanimously overturned a trial judge's dismissal of the law suit, which was filed in 2004 by 17 California pharmacies. 15 July 2010
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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