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Irish Parliamentarians last week passed the country's Health (Pricing and Supply of Medical Goods) Bill 2012 through both Houses of the Oireachtas, moves that were welcomed by Health Minister James Reilly and Alex White, Minister of State with responsibility for Primary Care in the Department of Health. 29 May 2013
Pharmaceutical
US drugmaker ISTA Pharmaceuticals has pleaded guilty to conspiracy to introduce a misbranded drug into interstate commerce and conspiracy to pay illegal remuneration in violation of the Federal Anti-Kickback Statute, the Justice Department announced on Friday (May 24). The guilty pleas are part of a global settlement with the USA in which ISTA agreed to pay $33.5 million to resolve criminal and civil liability arising from its marketing, distribution and sale of its drug Xibrom (bromfenac ophthalmic solution). 27 May 2013
Generics
Anglo-Swedish drug major AstraZeneca (LSE: AZN) announced last Friday (May 24) that the US Court of Appeals for the Federal Circuit issued a temporary injunction blocking generic manufacturers from distributing generic versions of Pulmicort Respules (budesonide inhalation suspension) in the USA until the Court rules on AstraZeneca's appeal of a District Court decision that found one patent protecting the product to be invalid and another patent not infringed. As a condition of the injunction, the Court has also ordered that AstraZeneca post a bond in the amount of $72 million. 27 May 2013
Generics
One of the most important preconditions for Turkey to reach a reformist, sustainable economic growth with high-added-value and to attract more direct foreign investment is to create an effective patent system at international standards, protecting intellectual property rights, comments the research-based Turkish pharma industry group, the AIFD. 20 May 2013
Generics
In the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA, a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories 9BSE; 500359) has pleaded guilty to felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of Ranbaxy's manufacturing facilities in India, the US Justice Department announced yesterday (May 13). 14 May 2013
Generics
Ireland-headquartered drugmaker Shire's (LSE: SHP) subsidiary Shire Development has prevailed in its US litigation against three companies (now trading as Actavis: NYSE: ACT) in connection with their Abbreviated New Drug Application for a generic version of Shire's Lialda (mesalamine) delayed release tablets for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. 10 May 2013
Biotechnology
Last Friday, the US state of Florida joined several states, most recently Indiana, in refusing to enact legislation that would create barriers between patients and newer, lower-cost versions of biologic medicines known as biosimilars. The Florida legislature voted to approve a bill on biosimilars that follows current substitution practices for prescription medicines, rejecting efforts by US biotech majors Amgen and Genentech (part of Roche) to limit future access to these therapies once they reach the market. 8 May 2013
Pharmaceutical
A law suit against pharmaceutical giant Pfizer (NYSE: PFE), for the permanent and devastating injuries their minor son suffered from birth defects allegedly caused by the firm's prescription antidepressant Zoloft (sertraline), that was prescribed to the mother during her pregnancy, has been launched by the boy's parents, Kori and Jami Wolcott, residents of Rochester, New York, according to law firm Lieff Cabraser Heimann & Bernstein. 7 May 2013
Generics
Within the next several weeks, the US Supreme Court is expected to hand down a ruling in an important case, Federal Trade Commission v Actavis Inc et al, which will address whether and when so-called "reverse payment" settlements (also called pay-for-delay deals) of pharmaceutical patent infringement law suits violate federal antitrust laws. 6 May 2013
Pharmaceutical
The US subsidiary of Japan's largest drugmaker Takeda Pharmaceuticals (TYO: 4502) USA announced that, in the case of Jack Cooper, et al v Takeda Pharmaceuticals America Inc et al., No CGC-12-518535, the judge granted Takeda's motion for non-suit. The ruling nullifies the jury's verdict last month, which had awarded plaintiffs $6.5 million in damages allegedly caused by the firm's diabetes drug Actos (pioglitazone; The Pharma Letter April 29). The trial began in February. 3 May 2013
Pharmaceutical
The European Medicines Agency has been ordered by the General Court of the European Union not to provide documents as part of two access-to-documents requests until a final ruling is given by the Court, a ruling which has wide implications for the pharmaceutical industry. 1 May 2013
Pharmaceutical
A US has jury found in favor of pharma giant Merck & Co (NYSE: MRK) in the Glynn versus Merck case in the US District Court for the District of New Jersey. In the case, the plaintiff claimed she used the company's osteoporosis drug Fosamax (alendronate sodium) and subsequently suffered an atypical femur fracture. 30 April 2013
Pharmaceutical
The US Department of Justice announced last Friday (April 26) that the government has filed a second civil false claims law suit against Swiss drug major Novartis' (NOVN: VX) US subsidiary, involving alleged "kickbacks" paid by the company to health care providers. 29 April 2013
Pharmaceutical
The US subsidiary of Japan's largest drugmaker, Takeda Pharmaceuticals (TYO 4502), says that in the case of Jack Cooper et al versus Takeda Pharmaceuticals America, No CGC-12-518535, the jury found in favor of the plaintiffs and awarded a total of $6.5 million in damages, with respect to the company's type 2 diabetes drug Actos (pioglitazone). 29 April 2013
Generics
The US District Court for the Central District of California issued a ruling recently in an unusual, if not unprecedented, case arising from alleged federal False Claims Act (FCA) violations where one drug manufacture has sued its competitor, said Delia Stubbs, writing on Hyman, Phelps & McNamara's FDA Law Blog. 28 April 2013
Pharmaceutical
In 2012, the pharmacy distribution market in Poland saw a decline for the first time in several years, reporting negative growth of -6%. Companies operating in the pharmaceutical market are poised to recover their market positions throughout 2013 after the revolution triggered by the entry into force of the Reimbursement Act. 23 April 2013
Generics
The UK's Office of Fair Trading (OFT) today (April 19) issued a Statement of Objections to certain pharmaceutical companies alleging they acted to delay effective competition in the UK supply of paroxetine, an antidepressant marketed by UK pharma giant GlaxoSmithKline (LSE: GSK) as Seroxat. Known as Paxil in the USA, the drug was one of GSK's biggest selling products before losing its European patent in 2006. 19 April 2013
Pharmaceutical
Several members of the US Congress this week echoed President Barack Obama's recycling of a "flawed policy proposal: imposing mandatory government price controls in Medicare Part D, cleverly disguised as rebates," according to industry lobby group Pharmaceutical Research and Manufacturers of America (PhRMA) senior vice president Matthew Bennett. 18 April 2013
Pharmaceutical
The Japanese Supreme Court has upheld high court rulings that the Japanese unit of Anglo-Swedish drug major AstraZeneca (LSE: AZN) carries no liability over fatal side effects caused by the lung cancer drug Iressa (gefitinib), reports the Japan Times and other local media. 17 April 2013
Biotechnology
USA-based Amgen (Nasdaq: AMGN), the world's largest independent biotech company, has agreed to pay the United States $24.9 million to settle allegations that it violated the False Claims Act, the US Justice Department announced on April 16. 17 April 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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