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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
The US subsidiary of Ireland-headquartered Shire will pay $56.5 million to resolve civil allegations that it violated the False Claims Act as a result of its marketing and promotion of several drugs, the US Justice Department announced yesterday. 25 September 2014
Pharmaceutical
The members of Greece’s pharma trade group SFEE have called on the government to urgently reset the amount of pharmaceutical expenditure at the minimum permissible limit of 2.3 billion euros ($2.95 billion) for the pharmaceutical budget and 700 million euros for the pharmaceutical costs of public hospitals. 22 September 2014
Generics
Following a public comment period, the US Federal Trade Commission has approved a final order settling charges that US generic drugmaker Akorn’s $440 million acquisition of VersaPharm and its parent company, VPI Holdings would have likely been anticompetitive. 21 September 2014
Generics
US Representatives Steve Stivers (Republican, Ohio) Peter Welch (Democrat, Vermont) on Thursday joined forces to introduce the Fair Access for Safe and Timely (FAST) Generics Act to increase consumer access to generic drugs, boost market competition and ultimately save consumers money. 19 September 2014
Pharmaceutical
UK pharma giant GlaxoSmithKline today announced that the Changsha Intermediate People’s Court in Hunan Province, China, ruled that GSK China Investment Co Ltd has, according to Chinese law, offered money or property to non-government personnel in order to obtain improper commercial gains, and been found guilty of bribing non-government personnel. 19 September 2014
Generics
The US Generic Pharmaceutical Association (GPhA) has identified areas in which the Generic Drug User Fee Act (GDUFA) process and implementation can be strengthened. 18 September 2014
Biotechnology
Biological warfare defense firm SIGA Technologies has filed a voluntary petition for relief under chapter 11 of the Bankruptcy Code in the US Bankruptcy Court for the Southern District of New York. 16 September 2014
Pharmaceutical
Partly in response to the recent (failed, thus far) attempt by US pharma giant Pfizer to acquire Anglo-Swedish peer AstraZeneca, the UK’s mergers and acquisition regulator is taking steps to give itself greater powers. 16 September 2014
Pharmaceutical
Hostile takeover target Allergan has said that value is what “really matters” in response to Pershing Square Capital Management’s delivery of additional requests from stockholders owning 1.5% of Allergan's shares to call a Special Meeting of Stockholders. 15 September 2014
Pharmaceutical
Swiss drug major Roche has said that compromised vials of its arthritis and cancer drug MabThera had been found in Germany. 15 September 2014
Generics
In what it says is its latest action to ensure competition in the nation’s health care markets, the US Federal Trade Commission has filed a complaint in federal district court charging several pharmaceutical companies with illegally blocking American consumers’ access to lower-cost versions of the testosterone replacement drug AndroGel. 9 September 2014
Pharmaceutical
US drug major Bristol-Myers Squibb and partner Japan’s Ono Pharmaceutical have filed a law suit against pharma giant Merck & Co over Keytruda (pembrolizumab) for advanced melanoma. 8 September 2014
Pharmaceutical
US specialty drugmaker Depomed says that Judge Kentaji Brown Jackson of the federal district court for the District of Columbia has granted the company’s motion for summary judgment in the company's law suit against the US Food and Drug Administration seeking an order requiring the FDA to grant Gralise (gabapentin) orphan drug exclusivity for the management of post-herpetic neuralgia (PHN). 7 September 2014
Biotechnology
The Full Bench of the Federal Court of Australia has decided a private company may hold a patent on a mutation in a breast cancer gene. 5 September 2014
Generics
A positive judgment has been given by the UK High Court in support of Israeli generic drug giant Teva Pharmaceutical Industries' case against Anglo-Swedish pharma major AstraZeneca. 3 September 2014
Generics
US biotech company United Therapeutics’ shares leapt 28.5% to $117.83 on Friday, after the company said that the US District Court for the District of New Jersey has ruled in its favor in the company's case against Sandoz, a generics subsidiary of Swiss pharma giant Novartis, regarding United’s Remodulin (treprostinil) product. 31 August 2014
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical and US pharma major Eli Lilly have failed in their attempt to overturn a combined $9 billion punitive damage award by a US jury for hiding cancer risks associated with their diabetes drug Actos (pioglitazone), according to a court ruling last week. 31 August 2014
Pharmaceutical
Hostile takeover target Allergan has asked the US District Court for the Central District of California to set an expedited schedule for discovery and a motion for a preliminary injunction against pursuant Valeant Pharmaceuticals International, Pershing Square Capital Management, and its principal, William Ackman, for violations of the federal securities laws. 27 August 2014
Generics
Ireland-headquartered generics major Actavis on Friday confirmed that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market rotigotine extended-release transdermal film. 23 August 2014
Pharmaceutical
US drug maker Depomed saw its shares climb more than 12% to $14.76 on Tuesday, on the news that the firm had received a positive court ruling relating to its Gralise (gabapentin). 20 August 2014
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