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In a five to four decision delivered yesterday by Chief Justice John Roberts, the US Supreme Court upheld most of President Barack Obama's signature health care reform act, or the Affordable Care Act dubbed "Obamacare," which has been strongly opposed by Republicans, who have said they would repeal the bill if they gained power. 29 June 2012
Generics
The US District Court for the Southern District of New York has found in favor of Israel's Teva Pharmaceutical Industries (Nasdaq: TEVA) in the company's patent infringement lawsuit against USA-based Momenta Pharmaceuticals (Nasdaq: MNTA)/Sandoz - a unit of Swiss drug major Novartis (NOVN: VX) and Mylan Laboratories (Nasdaq: MYL/India's Natco Pharmaceuticals (524816: BY) regarding Teva's relapsing-remitting multiple sclerosis drug Copaxone. 24 June 2012
Biotechnology
The US Congress has released a reconciled Prescription Drug User Fee Act (PDUFA) reauthorization bill that is effectively a comprise on two sets of legislation that were passed by the Senate (the Food and Drug Administration Safety and Innovation Act; FDASIA) and House of Representatives (PPDUFA), respectively, last month (The Pharma Letters May 28 and June 1). 20 June 2012
Pharmaceutical
The US District Court for the District of New Jersey has ruled against US drug giant Merck & Co (NYSE: MRK) in a patent infringement suit against Apotex Inc and Apotex Corp relating to the firm's allergy drug Nasonex (mometasone furoate monohydrate). 19 June 2012
Pharmaceutical
The US Food and Drug Administration announced in February that counterfeit vials of Roche/Genentech's cancer drug Avastin (bevacizumab) were sold to a number of medical practices across the country (The Pharma Letter February 16), notes intelligence provider GlobalData. 14 June 2012
Biotechnology
In the continuing saga of its hostile takeover bid for its partner on lupus drug Benlysta (belimumab), UK pharma giant GlaxoSmithKline plc (LSE: GSK) has extended its tender offer to acquire all of the outstanding shares of Human Genome Sciences (Nasdaq: HGSI) for US$13.00 per share in cash to 5:00 pm New York City time on June 29, 2012. The tender offer was previously scheduled to expire at the end of the day on June 7, at which time around 474,029 shares (including 24,856 shares subject to guarantees of delivery) - or around 0.2% - had been tendered and not withdrawn, pursuant to the offer. 10 June 2012
Generics
US generic major Mylan (Nasdaq: MYL) says that its subsidiary Mylan Pharmaceuticals has resolved all disputes with Teva Pharmaceuticals USA, stemming from litigation brought by Mylan in federal court in the District of Columbia against the US Food and Drug Administration concerning Mylan's Abbreviated New Drug Application for modafinil tablets, 100mg and 200mg. 10 June 2012
Pharmaceutical
Now that the US House of Representatives and the Senate have passed HR 5651 and S 3187 (the FDA Safety and Innovation Act), respectively, focus will move to a conference committee, which will iron out differences between the bills and reach a compromise, comments Karl Karst on law firm Hyman, Phelps & McNamara's FDA Law Blog. 4 June 2012
Generics
Just days after the US Senate overwhelming approved the Food and Drug Administration Safety and Innovation Act (FDASIA), which included reauthorization of the Prescription Drug User Fee Act (PDUFA; The Pharma Letter May 28), the House of Representatives followed suit, passing the Food and Drug Administration Reform Act of 2012 (HR 5651) in a 387 to five vote. 1 June 2012
Pharmaceutical
Anglo-Swedish drug major AstraZeneca's (LSE: AZN) Japanese subsidiary has received a decision from the Osaka High Court of Appeals in response to their appeal against the decision made by the Osaka District Court on 25 February 2011 regarding a law suit naming AstraZeneca and the Ministry of Health, Labor and Welfare (MHLW) as defendants, brought by (i) the bereaved families of three patients and (ii) one surviving patient,-claiming damages for the patients who suffered interstitial lung disease (ILD) side effects and, with the exception of the surviving patient, death following treatment with the company's lung cancer drug Iressa (gefitinib). 30 May 2012
Pharmaceutical
UK pharma giant GlaxoSmithKline (LSE: GSK) which has the marketing rights for Lovaza (omega-3-acid ethyl esters) in the USA and Puerto Rico, confirmed that US District Judge Sue Lewis Robinson, the presiding judge in the US District Court for the District of Delaware, ruled in Pronova BioPharma's (OSE: PRON.OL) favor in the latter's patent litigation involving US Patent Nos 5,656,667 and 5,502,077 covering Lovaza. 30 May 2012
Biotechnology
The US Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes a reauthorization of the Prescription Drug User Fee Act (PDUFA), last Thursday, in a move welcomed by both the Biotechnology Industry Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA). 28 May 2012
Biotechnology
Public Citizen strongly supports a measure proposed by US Senator Bernie Sanders (Independent, Vermont) that would more effectively curb fraudulent activity committed by the pharmaceutical industry against the federal and state governments, stated Sammy Almashat, a researcher at the US consumer advocacy group. 23 May 2012
Generics
Ireland-headquartered Warner Chilcott (Nasdaq: WCRX) has filed suit against USA-based Watson Pharmaceuticals (NYSE: WPI) on May 16, in the US District Court for the District of New Jersey seeking to prevent Watson from commercializing its Abbreviated New Drug Application for it contraceptive product prior to the expiration of US Patent Nos 5,552,394 and 7,704,984. 20 May 2012
Pharmaceutical
A UK Parliamentary group has warned that patients are suffering because of a shortage of some National Health Service prescription medicines. In its report, the All-Party Pharmacy Group (APPG) said the shortages had been mainly caused by the export of medicines intended for the UK market to other European Union countries. This exporting is conducted by speculators and is legal under EU and UK law, the report noted. 16 May 2012
Pharmaceutical
The US Food and Drug Administration's Arthritis Advisory Committee yesterday voted unanimously (11 to 0) against approval of US drugmaker Regeneron Pharmaceuticals' (Nasdaq: REGN) Arcalyst (rilonacept) injection for subcutaneous use for the proposed indication for the prevention of gout flares in patients initiating uric acid-lowering therapy 9 May 2012
Generics
German drug major Bayer (BAYN: DE) has launched an appeal against the Indian Patent Office, which a couple of months ago issued what was the first compulsory license in India to a generic drug manufacturer, Natco Pharmaceuticals (524816: BY), for its kidney and liver cancer drug Nexavar (sorafenib tosylate) under section 84 (1) (b) of the country's Patents Act (The Pharma Letter march 13). 8 May 2012
Pharmaceutical
Ending a four year investigation, US health care major Abbott Laboratories (NYSE: ABT) has reached a settlement with US federal and 49 state authorities, plus the District of Columbia, to resolve all outstanding issues regarding a previously disclosed investigation of past sales and marketing practices relating to its Depakote (divalproex), approved for the treatment of for the treatment of epilepsy, bipolar disorder and migraine 8 May 2012
Pharmaceutical
The US Food and Drug Administration yesterday approved Elelyso (taliglucerase alfa) for injection, an enzyme replacement therapy (ERT) for the long-term treatment of adults with a confirmed diagnosis of type 1 Gaucher disease, to be marketed by global pharma giant Pfizer (NYSE: PFE) under license from Israeli firm Protalix BioTherapeutics (NYSE-AMEX: PLX). 2 May 2012
Generics
Israel-based Teva Pharmaceutical Industries (Nasdaq: TEVA), the world's largest generics companies, said yesterday that it has settled patent infringement litigation regarding US Patent Number 7,132,570 with respect to US rival Mylan's (Nasdaq: MYL) Abbreviated New Drug Application for Teva's wakefulness product Nuvigil (armodafinil) tablets. 1 May 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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