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Pharmaceutical
BioFocus and Argenta, service companies of Netherlands-based Galapagos (Euronext: GLPG), yesterday announced they have entered into a multi-year collaboration agreement with Anglo-Swedish drug major AstraZeneca (LSE: AZN) to find new compounds against key targets of interest to AstraZeneca's research programs in respiratory and inflammatory diseases. 15 March 2012
Pharmaceutical
Anglo-Swedish drug major AstraZeneca (LSE: AZN) announced this morning that it has filed a law suit against the US Food and Drug Administration in the US District Court for the District of Columbia to overturn the FDA's denial on last week of the company's Citizen Petitions with regard to its antipsychotic drugs Seroquel (quetiapine fumarate) tablets and Seroquel XR extended release tablets (The Pharma Letter March 9). 13 March 2012
Pharmaceutical
US drugmaker Allergan (NYSE: AGN) revealed that US District Judge Andrew. Guilford, after conducting a full trial, ruled that Merz Pharmaceuticals and Merz Aesthetics, units of the German family-owned Merz Pharma GmbH, violated the California Uniform Trade Secrets Act and issued a permanent injunction against the companies. 13 March 2012
Generics
Ranking US Congress Member Henry Waxman, Health Subcommittee Ranking Member Frank Pallone, Representative John Dingell, Health Subcommittee Chairman Joe Pitts and Rep. Tim Murphy last month introduced HR 3988, titled the Generic Drug and Biosimilar User Fee Act of 2012. 6 March 2012
Generics
California, USA-based Depomed (Nasdaq: DEPO) yesterday filed a patent infringement law suit in the US District Court for the District of New Jersey against three companies that have filed Abbreviated New Drug Applications with the Food and Drug Administration to market generic Gralise (gabapentin). 5 March 2012
Pharmaceutical
US drugmaker Baxter International (NYSE:BAX) says that the European Commission has granted marketing authorization for its Avian flu vaccine Vepacel in all European Union member states, as well as Iceland, Liechtenstein and Norway. 5 March 2012
Pharmaceutical
USA-based Illumina (Nasdaq: ILMN) says that a federal jury in Wilmington, Delaware, found that certain of its TruSeq sample preparation and cluster generation kits and products infringe US Patent No 6,107,023, held by patent holder LadaTech (which is partly owned by the UK drugs giant GlaxoSmithKline). 4 March 2012
Pharmaceutical
The European Commission said yesterday that it has ceased its antitrust investigation into the pharmaceutical companies AstraZeneca (LSE: AZN) and Switzerland-based Nycomed, which is now owned by Japanese drug major Takeda (TYO: 4502), saying it found no evidence of illegal deals. 2 March 2012
Pharmaceutical
David Balto, an antitrust attorney in Washington DC, USA, and former Policy Director of the Federal Trade Commission, released a white paper yesterday exposing the flaws in efficiency claims made by US pharmacy benefit managers (PBMs) Express Scripts (Nasdaq: ESRX) and Medco Health Solutions (NYSE: MHS), with respect to their proposed merger. 20 February 2012
Pharmaceutical
US Attorney General Eric Holder and Department of Health and Human Services (HHS) Secretary Kathleen Sebelius have released a new report showing that the government's health care fraud prevention and enforcement efforts recovered nearly $4.1 billion in taxpayer dollars in fiscal year 2011, the highest annual amount ever recovered from individuals and companies who attempted to defraud seniors and taxpayers or who sought payments to which they were not entitled. 16 February 2012
Generics
Last week, US Representative Bobby Rush (Democrat, Illinois) introduced HR 3995, the Protecting Consumer Access to Generic Drugs Act of 2012. The bill is the latest piece of legislation that attempts to stymie so-called pay-for-delay patent settlement agreements, notes Hyman, Phelps & McNamara's Kurt Karst writing on the law firm's FDA Law Blog. 14 February 2012
Pharmaceutical
Attorneys from Sanford Wittels & Heisler have filed a class action complaint in the US District Court for the Southern District of New York on behalf of four former sales representatives and other similarly-situated employees at LEO Pharma Inc, the US unit of Denmark's privately-held LEO Pharma. 9 February 2012
Generics
US generic drugmaker Watson Pharmaceutical (NYSE: WPI) says that its subsidiary, Watson Laboratories, has reached a settlement with Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Pharmaceuticals (formerly Ortho-McNeil-Janssen Pharmaceuticals) on outstanding patent litigation related to Watson's generic version of Janssen's oral contraceptive Ortho Tri-Cyclen LO (norgestimate/ethinyl estradiol) tablets. 8 February 2012
Generics
French drug major Sanofi (Euronext: SAN) this morning reported 8.8% growth in fourth-quarter 2011 sales to 8.51 billion euros ($11.16 billion), in-line with consensus forecasts of the same amount, driven by Pharmaceuticals business revenues of 7.22 billion euros (+10.5%), Diabetes business of 1.24 billion euros (+12.5%), US biotech subsidiary Genzyme sales of 831 million euros (+0.8%), Consumer Health Care sales of 645 million euros (+15.4%), generics sales of 488 million euros (+21.0%), and Animal Health business to 470 million euros (+10.0%), offset by 8.1% decline in Sanofi Pasteur sales to 818 million euros. 8 February 2012
Generics
US Representatives John Carney (Democrat, Delaware) and Larry Bucshon (Republican, Indian) last week introduced the Drug Shortage Prevention Act, HR 3839, to address the scarcity of certain pharmaceutical drugs in the USA's marketplace. 6 February 2012
Pharmaceutical
US District Court Judge Joseph Tauro has ordered the complete dismissal of a whistleblower law suit against Millennium Laboratories, a US research-based medication monitoring company, brought by a former Calloway Laboratories' senior officer. 5 February 2012
Generics
US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) says that its subsidiary, Watson Laboratories, has reached a settlement with Mallinckrodt NYSE: MKG) on outstanding patent litigation related to Watson's generic versions of Mallinckrodt's long-acting prescription pain drug Exalgo (hydromorphone hydrochloride) extended-release tablets. 29 January 2012
Generics
The US Department of Justice, on behalf of the Food and Drug Administration, has filed a consent decree of permanent injunction against Indian generic drug manufacturer Ranbaxy in the US District Court of Maryland. The consent decree was filed against Ranbaxy Laboratories (RANB: BO), a 64% owned subsidiary of Japan's Daiichi Sankyo, its subsidiary Ranbaxy Inc, and several of the group's executives. 27 January 2012
Generics
After almost three years of waiting since three petitioners living with HIV filed a constitutional petition challenging the implementation of a law on anti-counterfeiting, the Kenyan High Court is due to deliver a verdict on March 9, reports Health Action International Africa. 27 January 2012
Pharmaceutical
The US subsidiary of Swiss drug major Novartis (NOVN: VX) says it has reached an agreement to resolve the nationwide Wage and Hour class action against the company currently pending in the US District Court for the Southern District of New York. 25 January 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
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