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Generics
Israel’s Teva Pharmaceutical Industries, the USA’s Endo Pharmaceuticals and Japanese drugmaker Teikoku Pharma will pay $70 million and have agreed to temporarily avoid pay-for-delay deals to end allegations they illegally delayed cheaper alternatives to the narcolepsy drug Provigil (modafinil) and the pain treatment Lidoderm (lidocaine), California’s Attorney General said Monday, according to media reports. 30 July 2019
Pharmaceutical
The trade group representing pharma in Australia is angry that the government has proposed legislation on intellectual property (IP) has failed to heed its recommendations. 26 July 2019
Biotechnology
US biotech Celgene has agreed to pay $55 million to settle a class action lawsuit over alleged attempts by the drugmaker to block generic competition. 24 July 2019
Pharmaceutical
The US District Court for the District of Columbia (District Court) granted Braeburn Pharmaceutical’s (Nasdaq: BBRX) motion for summary judgment, vacating the US Food and Drug Administration’s December 2018 exclusivity determination which blocked Brixadi (buprenorphine) extended release injection from final approval through November 30, 2020. 24 July 2019
Biotechnology
The Düsseldorf Regional Court has found that Praluent (alirocumab) infringes the German part of US biotech firm Amgen’s European patent (EP 2 215 124), relating to rival product Repatha (evolocumab), directed to antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). 15 July 2019
Pharmaceutical
US-based drugmaker Johnson & Johnson is facing litigation under the False Claims Act, over the $2.4 billion blockbuster prostate cancer drug Zytiga (abiraterone acetate). 12 July 2019
Pharmaceutical
The European Commission has approved, under the EU Merger Regulation, the acquisition of US pharma giant Pfizer's Consumer Health Business by UK major GlaxoSmithKline. 11 July 2019
Pharmaceutical
UK-headquartered consumer products giant Reckitt Benckiser today announced it has reached agreements with the US Department of Justice (DoJ) and the Federal Trade Commission to resolve the long-running investigation into the sales and marketing of Suboxone (buprenorphine and naloxone) Film by its former prescription pharmaceuticals business Indivior, a business that was wholly demerged in 2014. 11 July 2019
Generics
Ayesha Raghib, associate at IP law firm Powell Gilbert, provides an Expert View on the imminent introduction of legislation that could prompt a spike in pharma litigation. 27 June 2019
Generics
The UK’s Competition and Markets Authority (CMA) has accused competitors King and Auden Mckenzie of sharing out between them the supply of nortriptyline to a large pharmaceutical wholesaler. 20 June 2019
Pharmaceutical
New legal action from Catalyst Pharmaceuticals signals the Florida, USA-based firm’s intention to strongly defend its market share in the rare disease Lambert-Eaton myasthenic syndrome (LEMS). 13 June 2019
Pharmaceutical
A letter accidentally filed by the US Department of Justice (DoJ) shows that the US Government and Novartis have made "significant progress" settling claims that the Swiss pharma giant paid kickbacks to doctors. 13 June 2019
Pharmaceutical
Embattled opioid manufacturer Insys Therapeutics has filed for bankruptcy in the USA, shortly after agreeing to $225 million in charges with the US Department of Justice (DOJ), following allegations of marketing malpractices. 10 June 2019
Biotechnology
In yet a further delay to the transaction, Swiss pharma giant Roche and Spark Therapeutics today announced that they have each received a request for additional information and documentary material from the US Federal Trade Commission (FTC) in connection with the agency’s review of Roche’s pending $4.3 billion acquisition of Spark announced in February this year. 10 June 2019
Pharmaceutical
UK-incorporated specialty pharma firm Mallinckrodt says it has “reached an agreement in principle” with the US Department of Justice (DOJ) to pay $15.4 million relating to allegations of kickbacks. 6 June 2019
Pharmaceutical
Opioid manufacturer Insys Therapeutics has agreed to a global resolution to settle the government’s separate criminal and civil investigations, the Department of Justice announced today. 6 June 2019
Pharmaceutical
China’s Ministry of Finance will open up the books of 77 drugmakers as part of an accounts probe that was announced on Tuesday. 5 June 2019
Pharmaceutical
“If Congress weakens patent laws, patients may never benefit from new treatments or cures." 30 May 2019
Pharmaceutical
Spanish dermatology specialist Almirall and its US affiliate, formerly known as Aqua Pharmaceuticals, have agreed to pay the United States $3.5 million to resolve allegations that they used kickbacks to induce physicians to purchase their dermatology products. 30 May 2019
Generics
US affiliates of Israeli generics giant Teva Pharmaceutical Industries have entered into an agreement for a one-time payment of $85 million to the state of Oklahoma, it was announced on Sunday. 28 May 2019
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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