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Germany's Merck KGaA (MRK: DE) says that a Pennsylvania appeals court has ruled against Merck in deciding the termination date for the co-promotion agreement with global pharma behemoth Pfizer (NYSE: PFE) on multiple sclerosis drug Rebif (interferon beta-1a) in the USA, saying that the agreement entered into in July 2002 extends until December 31, 2015. 16 April 2013
Pharmaceutical
A US federal judge has ordered the Food and Drug Administration to lift age and other restrictions on the sale of the morning-after pill, making the drug available to women of all ages over the counter. 5 April 2013
Biotechnology
USA based Cyclacel Pharmaceuticals (Nasdaq: CYCC) says that it has entered into a definitive agreement with biotech major Celgene (Nasdaq: CELG) to sell to Celgene four Cyclacel-owned patents related to the use of romidepsin injection. In connection with the agreement Celgene has made a one-time payment of $5.5 million to Cyclacel. 5 April 2013
Pharmaceutical
The US Court of Appeals in Boston has upheld a $142.1 million damage award to Kaiser Foundation Health Plan over pharma behemoth Pfizer's (NYSE: PFE) marketing of its epilepsy drug Neurontin (gabapentin). It also found a lower-court judge erred in refusing to allow so-called "third- party payers," such as health insurers and union funds, to combine their Neurontin racketeering claims, report Bloomberg and other US media. 5 April 2013
Generics
Acquisitive Canadian drugmaker Valeant Pharmaceuticals International (TSX: VRX) today (April 3) announced that its takeover target Obagi Medical Products (Nasdaq: OMPI) has accepted its increased offer of $24.00 per share (up from an original $19.75 made last month , which tops that of German family-owned Merz Pharma's $22.00 per share counter offer (The Pharma Letters April 2 and March 20). 3 April 2013
Biotechnology
The US State of Florida Senate Committee on Health Policy has passed Senate Bill (SB) 732. Under this proposed legislation, Florida would permit automatic substitution of biosimilar medicines that the Food and Drug Administration has deemed interchangeable and put in place key measures to help doctors maintain accurate records of what medicine their patient received. Unlike the European Union, the USA still does not have nation-wide legislation on biosimilars, although the FDA is currently working on this. 3 April 2013
Generics
In a landmark decision issued on Monday (April 1) by the Indian Supreme Court has denied Swiss drug major Novartis' (NOVN: VX) patent on the blockbuster cancer drug Glivec (imatinib mesylate). Shares in Novartis' Indian unit ended 1.8 % lower after falling as much as 6.8% after the verdict, noted a Reuters report. European markets were closed for the Easter holiday. 2 April 2013
Biotechnology
A new law in the US state of Virginia signed into law last week by Governor Bob McDonnell - designed to address the regulatory issues related to the interchangeability of biological medicines - forbids pharmacists from dispensing a biosimilar substitution to a brand-name biologic drug if the prescribing physician specifies the prescription must be dispensed as written or if a patient wants the branded drug. 25 March 2013
Generics
India's second largest drugmaker Dr Reddy's Laboratories (NYSE: RDY) said last Friday (March 22) that it had settled its claims against Canada-based contract research organization Nordion (TSX: NDN, formerly MDS Inc) in a case pending in the US District Court for the District of New Jersey, for a cash payment of $22.5 Million by Nordion. The settlement was concluded on March 20, 2013, with the receipt of the settlement funds by Dr Reddy's. 24 March 2013
Generics
The US Supreme Court on Tuesday heard arguments on whether Americans who suffer side effects caused by generic drugs can hold the drugmaker liable. This case, Mutual Pharmaceutical v Bartlett, will decide the responsibility generic makers have in the overall design of the drugs they produce. The Court is expected to announce its ruling later this year. 20 March 2013
Pharmaceutical
The independent drugstore lobby is again seeking special antitrust exemptions (HR 1188) that would empower independent drugstores to charge consumers, employers, unions, and government agencies higher prescription drug prices, says the USA's Pharmaceutical Care Management Association (PCMA). 18 March 2013
Biotechnology
The US Federal Trade Commission has filed an amicus brief in the US District Court for the District of New Jersey explaining that brand name drug manufacturers may improperly use restricted drug distribution programs to impede generic competition. The Commission vote approving the filing of the amicus brief was four to zero. 13 March 2013
Generics
US generic drugmaker Par Pharmaceutical NYSE: PRX) pleaded guilty in federal court yesterday (March 6) and agreed to pay $45 million to resolve its criminal and civil liability in the company's promotion of its prescription drug Megace (megestrol acetate) ES for uses not approved as safe and effective by the Food and Drug Administration and not covered by federal health care programs, the Justice Department announced. 7 March 2013
Pharmaceutical
In 2011, pharmaceutical distribution was liberalized in Central Europe, with Bulgaria making the on-line sale of medicines legal in March. 2012 brought the opposite trend. The Reimbursement Act in Poland imposed a ban on advertising by pharmacies, among other regulations which made the operational environment for most distribution concerns much harder. 5 March 2013
Biotechnology
The Italian antitrust authority has opened a cartel investigation of Swiss drug majors Novartis (NOVN: VX) and Roche (ROG: SIX) over allegations they colluded to keep their drugs Avastin (bevacizumab) and Lucentis (ranibizumab injection), used for the treatment of macular degeneration, off the country's market. 21 February 2013
Generics
Ukraine's Association of Pharmaceutical Research and Development, APRAD, has written to the country's President appealing for amendments to some of the proposed moves on the licensing of imports of medicines and the definition of "active pharmaceutical ingredient" that was passed by the Parliament last year (The Pharma Letter August 6, 2012). 18 February 2013
Generics
US pharma giant Merck & Co (NYSE: MRK) said yesterday that it has reached an agreement in principle with plaintiffs to resolve two federal securities class-action law suits, agreeing to pay $688 million over disclosures concerning a 2008 drug study dubbed EHNACE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) evaluating Vytorin and Zetia. 15 February 2013
Generics
AstraZeneca announced that, on 14 February 2013, the United States Court of Appeals for the Federal Circuit summarily upheld a lower court ruling that had found the formulation patent protecting its blockbuster antipsychotic Seroquel XR (quetiapine fumarate) extended release tablets in the US to be valid and infringed. 15 February 2013
Generics
The Indian patent office has again ruled in favor of domestic drugmaker Cipla (BSE: 500087), reinstating its earlier decision to revoke pharma behemoth Pfizer's (NYSE:PFE) patent for kidney cancer agent Sutent (sunitinib) in India, Cipla counsel and managing partner of the law firm Singh & Singh, Prathiba Singh, told the local newspaper Business Standard. 12 February 2013
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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