Legal
Refine Search
Pharmaceutical
The European Union's highest court, the Court of Justice, yesterday dismissed the appeal of Anglo-Swedish drug major AstraZeneca (LSE: AZN) regarding a fine of 52.5 million euros ($68.3 million; reduced from 60 million euros) imposed on the company for two alleged abuses of a dominant market position relating to blocking or delaying generic copies of the firm's blockbuster anti-ulcerant drug Losec (omeprazole), in a case that goes back to 2005 (The Pharma Letter July 2, 2010). 7 December 2012
Pharmaceutical
Washington DC, USA-based non-profit legal watchdog group Citizens for Responsibility and Ethics (CREW) said yesterday that it has filed a motion to quash a subpoena served on it by Sanofi Pasteur, the vaccines unit of French drug major Sanofi (Euronext: SAN) in connection with a law suit doctors have filed against the company alleging anti-competitive practices. 6 December 2012
Pharmaceutical
The US Court of Appeals for the Second Circuit (based in New York City) on December 3 issued a long-awaited ruling in United States versus Caronia, a case involving off-label promotion of a pharmaceutical product, according to a posting on Hyman, Phelps & McNamara's FDA Law Blog. 5 December 2012
Pharmaceutical
After more than 12 weeks of hearings in India's Supreme Court, humanitarian aid agency Medecins Sans Frontieres (MSF) says it has learnt that final arguments into the Novartis versus Union of India case challenging the interpretation of Section 3d of India's patent law have today come to an end. 5 December 2012
Generics
US Congressman Bill Cassidy, a medical physician (Republican, Louisiana) and four colleagues, last week introduced the Patient Access to Drugs in Shortage Act (HR 6611). He introduced the bill with Congressmen Andy Harris (Rep, Maryland), Mike Rogers (Rep, Michigan), Tom Rooney (Rep, Florida) and Dan Benishek (Rep, Michigan), that they say could make it worth the while of drugmakers to produce these drugs and even draw some branded makers back into the market with tax incentives. 3 December 2012
Generics
The USA's Federal Trade Commission revealed yesterday that it has filed an amicus brief before the US District Court for the Eastern District of Pennsylvania explaining that minor, non-therapeutic changes to a branded pharmaceutical product that harm generic competition can constitute exclusionary conduct that violates the nation's antitrust laws. 27 November 2012
Generics
Humanitarian health organization Medecins Sans Frontieres (MSF) says it continues to follow progress of the case currently unfolding in India's Supreme Court. The question of what deserves a patent, enshrined in Section 3(d) of the country's patent law, is at the crux of Swiss drug major Novartis' (NOVN: VX) six year legal battle against the Indian government, which has now reached the Supreme Court (The Pharma Letters passim). 18 November 2012
Biotechnology
USA-based Alnylam Pharmaceuticals (Nasdaq: ALNY) says it has restructured its relationship with Canadian developer of RNA interference (RNAi) therapeutics Tekmira Pharmaceuticals (Nasdaq: TKMR), with a new licensing agreement and resolution of all litigation between the parties in a settlement agreement. Under the deal, Tekmira will receive $65 million within 10 days and is eligible for a further $10 million in near-term milestone payments expected in 2013. 14 November 2012
Generics
The Russian Federal Antimonopoly Service suspects the existence of cartel agreement in the Russian pharmaceutical market, the members of which concurrently raise prices for their drugs. 11 November 2012
Generics
There was disappointing news for global pharma behemoth Pfizer (NYSE: PFE) yesterday, when the Canadian Supreme Court annulled the firm's patent on Viagra (sildenafil), its blockbuster erectile dysfunction drug. 9 November 2012
Biotechnology
The US Food and Drug Administration recently announced that the agency has established within the Center for Drug Evaluation and Research (CDER) an Exclusivity Board "to provide oversight and recommendations regarding exclusivity determinations made by the Center, with a primary focus on clarity and consistency of decisions," notes Kurt Karst, writing on Hyman, Phelps & McNamara's FDA Law Blog. 7 November 2012
Pharmaceutical
The US subsidiary of independent German drug major Boehringer Ingelheim has agreed to pay $95 million to resolve allegations under the False Claims Act relating to the improper promotion of the stroke-prevention drug Aggrenox (aspirin/extended-release dipyridamole), the chronic obstructive pulmonary disease (COPD) drugs Atrovent (ipratroprium) and Combivent (ipratropium bromide and salbutamol, and the hypertension drug Micardis (telmisartan), the US Justice Department announced last week. 29 October 2012
Generics
US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) said on Friday that it has launched a generic version of Japanese drug major Takeda's (TYO: 4502) type 2 diabetes drug Actos (pioglitazone 15mg, 30mg and 45mg tablets) after receiving final approval from the US Food and Drug Administration, and began shipping the product immediately. 29 October 2012
Pharmaceutical
European Union-certified pharmaceuticals will be exported to Israel and vice-versa without requiring additional certification in the importing country, under a deal endorsed by the Parliament on Tuesday, despite reservations that easing trade with Israel could send it the wrong political signal at this time. 24 October 2012
Generics
The USA's Federal Trade Commission will require Watson Pharmaceuticals (NYSE: WPI) and fellow generic drugmaker Actavis to sell the rights and assets to 18 drugs to Sandoz International (the generics unit of Novartis) and US firm Par Pharmaceuticals, and relinquish the manufacturing and marketing rights to three others, to settle charges that Watson's proposed $5.9 billion acquisition of Actavis (The Pharma Letter April 26) would otherwise be anticompetitive. Watson has agreed to make the divestments. 16 October 2012
Generics
US generic drugs major Mylan (Nasdaq: MYL) has entered into a patent settlement with Japan's Shionogi (TYO: 4507) and its US unit CIMA Labs that will resolve patent litigation related to their Orapred ODT (prednisolone sodium phosphate orally disintegrating tablets) (ODT), 10mg, 15mg and 30mg, a treatment of certain pulmonary diseases such as asthma. 11 October 2012
Generics
The US Federal Trade Commission this week filed an amicus brief in the US District Court for the District of New Jersey stating that an agreement by a branded drug company not to launch an authorized generic (AG) drug "provides a convenient method for branded drug firms to pay generic patent challengers for agreeing to delay entry." 10 October 2012
Generics
In yet another setback for research-based pharmaceutical companies, last week the Indian patent office revoked US drugs behemoth Pfizer's(NNYSE: PFE) patent for an anti-cancer drug in that country, the Indian Business Standard reported. 8 October 2012
Generics
At the request of the US Federal Trade Commission, the Solicitor General of the USA petitioned the country's Supreme Court to review a recent federal appeals court ruling concerning the FTC's case against a "pay-for-delay" agreement that postponed generic competition for the testosterone-replacement drug AndroGel. The filing, a petition for certiorari, was made with the Court last Thursday. The Supreme Court case is Federal Trade Commission v Watson Pharmaceuticals Inc, No 12-416. 8 October 2012
Biotechnology
Legislation co-sponsored in the USA by Representatives Brian Bilbray (Republican, California), Carolyn Maloney (Democrat, New York) and Rosa DeLauro (Democrat, Connecticut), and supported by the Melanoma Research Foundation, seeks to encourage the development of so-called "significant drug combinations" by offering the carrot of an extension of marketing exclusivity. 4 October 2012
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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze