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Generics
The USA's Generic Pharmaceutical Association (GPhA) says that it has filed an Amicus Brief ("friend of the court" or a person with strong interest in or views on the subject matter of an action, but not a party to the action) in the Upsher-Smith versus Louisiana Wholesale Drug Co relating to patent settlements. 3 October 2012
Pharmaceutical
US health care major Abbott Laboratories (NYSE: ABT) was sentenced by US District Court Judge Samuel Wilson of the Western District of Virginia in connection with its guilty plea related to its unlawful promotion of the prescription drug Depakote (divalproex) for uses not approved as safe and effective by the Food and Drug Administration, the Justice Department announced yesterday. 3 October 2012
Pharmaceutical
Individual states in the USA are settling more cases than ever with pharmaceutical companies accused of defrauding their Medicaid programs and are recovering taxpayer money at record amounts from those settlements, according to the findings of a new report from consumer advocacy Public Citizen. In an era of ever-tighter Medicaid budgets, many states have recovered just as much, if not more, money from this litigation as they spent on all Medicaid fraud enforcement. 30 September 2012
Pharmaceutical
US drugmaker Depomed (Nasdaq: DEPO) says it has filed an action in federal district court for the District of Columbia against the Food and Drug Administration, seeking an order requiring the FDA to grant Gralise (gabapentin) Orphan Drug exclusivity for the management of postherpetic neuralgia (PHN). 26 September 2012
Pharmaceutical
To address the growing costs and concerns about the overuse of antipsychotics in nursing homes and other long-term care facilities in the USA, US Senators Herb Kohl (Democrat, Wisconsin) Chuck Grassley (Republican, Iowa) and Richard Blumenthal (Democrat, Connecticut) last week introduced new bipartisan legislation. 25 September 2012
Pharmaceutical
Global pharma behemoth Pfizer (NYSE: PFE) must face the music over allegations that Wyeth, a subsidiary if Pfizer since 2009, had committed securities fraud by misleading investors about the risk of serious side effects with its antidepressant Pristiq (desvenlafaxine), after US District Judge Richard Sullivan in Manhattan granted class-action status to former Wyeth shareholders. 19 September 2012
Pharmaceutical
The number of patent infringement actions filed in 2011 reached 4,015 - the highest number ever recorded, according to data compiled in the 2012 Patent Litigation Study released last week by PricewaterhouseCoopers (PwC) US. 18 September 2012
Generics
Over the weekend, the Intellectual Property Appellate Board (IPAB) of Chennai, India, has dismissed the plea by German pharmaceutical company Bayer (BAYN: DE), which was seeking a stay on the compulsory license issued by the Indian Patent Controller to Indian generics drugmaker Natco Pharma (524816: BY) to manufacture generic versions of the anti-cancer Nexavar (sorafenib tosylate; The Pharma Letter March 13), Bayer confirmed to TPL yesterday, but stressing that it has not rejected the company's main appeal. 18 September 2012
Generics
In a special report in the prestigious medical journal The Lancet, researchers from Queen Mary, University of London, UK, argue that pending cases against India's patent laws threaten public health and misinterpret international intellectual property agreements. 11 September 2012
Generics
SFJ Pharmaceuticals Group, a global drug development group of companies which provides a unique co-development partnering model (SFJ), has entered into a collaborative ement with Pfizer (NSE: PFE) to conduct a Phase III clinical trial of the pharma behemoth's investigational pan-HER (pan-human epidermal growth factor receptor) inhibitor, dacomitinib (PF-00299804). 10 September 2012
Pharmaceutical
The Food and Drug Administration has dragged its feet for too long on a petition calling on the agency to stop allowing the drug Aricept (donepezil), marketed by originator Japan's Eisai (TYO: 4532) and US drug behemoth Pfizer (NYSE: PFE) to be marketed at doses that can cause severe - and even fatal - side effects, US consumer advocacy group Public Citizen said in a law suit filed this week. The suit asks the court to compel the FDA to act. 7 September 2012
Generics
US drugmaker Santarus (Nasdaq: SNTS) saw its shares leap 14.2% to $7.06 in regular trading on September 4, adding a further 2.8% after hours, after the company said that the US Court of Appeals for the Federal Circuit reversed in part a lower court decision of invalidity involving certain asserted patent claims covering Zegerid (omeprazole/sodium bicarbonate) capsules and powder for oral suspension. 6 September 2012
Generics
German drug major Bayer (BAYN: DE) yesterday headed to India's Intellectual Property Appellate Board in Chennai in a bid to overturn a compulsory licence which has allowed more affordable generic versions of its cancer drug Nexavar (sorafenib tosylate), to be produced in the interests of public health, said the international humanitarian health organization Medecins Sans Frontieres (MSF) which criticized Bayer for the move. 4 September 2012
Pharmaceutical
US health care giant Johnson & Johnson's (NYSE: JNJ) Janssen Pharmaceuticals yesterday announced a settlement and consent decree with 36 states and the District of Columbia regarding previously disclosed allegations related to inappropriate promotional and marketing practices for its atypical antipsychotic drug Risperdal (risperidone). 31 August 2012
Pharmaceutical
US drug major Eli Lilly (NYSE: LLY) revealed last Friday that the primary endpoints, both cognitive and functional, were not met in either of the two Phase III, double-blind, placebo-controlled solanezumab EXPEDITION trials in patients with mild-to-moderate Alzheimer's disease. Nevertheless, Lilly's shares rose 3.4% on Friday to $43.86, as the company indicated that the drug showed some potential to help in mild cases of the disease. 28 August 2012
Pharmaceutical
Indian drugmaker Glenmark Pharmaceuticals saw its shares rise 2.3% to 415 rupees yesterday after the company revealed that the International Centre for Dispute Resolution (ICDR) ruled in favor of the company on the arbitration claim it filed on August 8, 2011 against Napo Pharmaceuticals relating to Crofelemer, a proprietary proanthocyanidin for the treatment of diarrheal diseases. 23 August 2012
Pharmaceutical
Humanitarian organization Medecins Sans Frontieres (MSF) said yesterday that it has learnt that the Indian Supreme Court case of Novartis versus the government of India has been re-scheduled for Tuesday, 11 September 11, 2012. The case, already postponed from a July start, was supposed to begin final arguments on August 22 (The Pharma Letter August 21). The postponement is due to other pending cases which need to be heard. 23 August 2012
Generics
India's Intellectual Property Appellate Board (IPAB) in Chennai has postponed hearing the appeal by German pharmaceutical major Bayer over the granting of a compulsory licence for its cancer drug Nexavar (sorafenib tosylate) to Indian generic company Natco Pharma (524816: BY) until Monday September 3, Bayer confirmed to The Pharma Letter, without explaining the reason for the delay from the scheduled start of August 21. 22 August 2012
Pharmaceutical
French drug major Sanofi's (Euronext: SAN) USA-based rare diseases subsidiary Genzyme is pulling leukemia drug Campath (alemtuzumab) from the market to prepare for its launch under a different dosage and as a multiple sclerosis treatment that will be branded as Lemtrada, according to a report from Reuters. 21 August 2012
Generics
US generic drugmaker Watson Pharmaceuticals (NYSE: WPI) says it has filed suit against the US Food and Drug Administration challenging the agency's decision regarding Watson's entitlement to shared exclusivity for its copy version of Japanese drug major Takeda Pharmaceutical's (TYO: 4502) blockbuster type 2 diabetes drug Actos (pioglitazone hydrochloride 15mg, 30mg and 45mg tablets). 16 August 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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