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UK pharmaceutical giant GlaxoSmithKline (LSE: GSK) last night announced that it has finalized a previously reported agreement in principle with the US Attorney's Office for the District of Massachusetts and the US Department of Justice with respect to the investigation of the company's former manufacturing facility in Cidra, Puerto Rico. 27 October 2010
Generics
Japanese drug major Daiichi Sankyo (TSE 4568) yesterday launched its anti-influenza treatment Inavir (laninamivir octanoate) Dry Powder Inhaler 20mg in Japan. The drug - developed in cooperation with Australia's Biota - was approved for manufacture and marketing last month (The Pharma Letter September 14) and drug price listing was effected on October 4. 20 October 2010
Pharmaceutical
A number of US government officials unanimously predicted a dramatic increase in the number of criminal prosecutions of individuals for violations of laws governing Food and Drug Administration-regulated industries, at a recent Food and Drug Law Institute (FDLI) conference held in Washington DC. 18 October 2010
Pharmaceutical
Carrying through on a previous warning, the US Justice Department is investigating ways that leading pharmaceutical companies could be paying bribes overseas to boost sales and speed approvals, according to a report by the Wall Street Journal. 6 October 2010
Pharmaceutical
Swiss drug major Novartis (NOVN: VX) says its US subsidiary, Novartis Pharmaceuticals Corp (NPC), has reached a global resolution with the US Attorney's Office for the Eastern District of Pennsylvania (EDPA) regarding the previously disclosed investigation into civil and criminal allegations of the off-label promotion of Trileptal (oxcarbazepine), as well as civil allegations relating to five other products, including its top-selling drug Diovan (valsartan) - which generated sales of some $6 billion last year, Exforge (amlodipine/valsartan), Sandostatin (octreotide, Tekturna (aliskiren) and Zelnorm (tegaserod). Under the agreement, the company will pay a total of $422.5 million in criminal and civil claims. 1 October 2010
Pharmaceutical
French drug major Sanofi-Aventis (Euronext: SAN) has announced the top-line results of the Phase III GETGOAL-L-ASIA study assessing the efficacy and safety of lixisenatide, a once-daily GLP-1 receptor agonist, in combination with basal insulin, showing that its product significantly improved glycemic control. The study also confirmed that there are no specific safety concerns with lixisenatide in patients with type 2 diabetes. The drug is licensed from Danish firm Zealand Pharma. 1 October 2010
Pharmaceutical
The US Health Resources and Services Administration (HRSA) has issued two Advanced Notices of Proposed Rulemaking and Requests for Comment announcing its preliminary plans, and requesting stakeholder input, on how best to implement new authorities over the 340B Drug Pricing Program conferred by section 7102(a) of the Patient Protection and Affordable Care Act (PPACA), reports US law firm Hyman, Phelps & McNamara. 24 September 2010
Pharmaceutical
Members of the European Parliament yesterday adopted by an overwhelming majority (559 to seven) the text on the proposals for a directive and a regulation on pharmacovigilance. The proposal is the first section of the 'pharmaceutical package' of legislation to be adopted. 23 September 2010
Pharmaceutical
UK pharmaceutical giant GlaxoSmithKline (LSE: GSK) has filed a law suit in the USA against Swiss drug major Roche (ROG.VX), claiming it made antibodies, including Roche's blockbuster cancer drug Herceptin (trastuzumab) ' which generated first-half 2010 sales of around $2.78 for the Swiss group, that infringed two of its patents, according to a batch of news reports including from Dow Jones and Swiss Info. 23 September 2010
Generics
Changes to the regulation of the Russian pharmaceutical market are coming into effect or have been proposed during 2010 by the Health and Social Development Ministry. The changes come in response to recent increases in the cost of drugs and the H1N1/swine flu epidemic. The Ministry is also concerned about administrative barriers in the registration process for drugs and the fees payable to the network of controlling agencies and expert organizations, wrote Kirill Saturov, senior attorney, and Derek Bloom, a partner, at Capital Legal services in a recent issue of the Moscow Times. 22 September 2010
Biotechnology
The US Food and Drug Administration and the Centers for Medicare and Medicaid Services (CMS) are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review. 21 September 2010
Pharmaceutical
The staff of the USA's Federal Trade Commission has advised a consortium of pharmaceutical and biotechnology companies that it has no present intention to recommend that the agency challenge the Consortium's planned joint supplier quality and safety audit programs. Under these programs, consortium members will be able to share both prior quality and safety audit information and the costs of sponsoring further quality and safety audits of common suppliers. 21 September 2010
Biotechnology
The US Food and Drug Administration says it has begun a safety review of Japanese drug major Takeda Pharmaceutical's (TSE: 4502) diabetes type 2 drug Actos (pioglitazone), after receiving preliminary results from a long-term observational study funded by the company designed to evaluate the risk of bladder cancer associated with use of this drug. 20 September 2010
Pharmaceutical
A study reported in the 2010 issue of Health Affairs has found that costs related to medical liability account for more than $55 billion a year or 2.4% of the total costs to the US health care system. According to the study, approximately 80%, or $45 billion of these costs are the result of defensive medicine, procedures performed to avoid unnecessary litigation. 20 September 2010
Pharmaceutical
A unit of the government of Ukraine last week filed suit in federal court in Portland, Oregon, USA, against a US company that is alleged to be part of an international conspiracy involving the fraudulent sale of vaccines and other pharmaceuticals. 20 September 2010
Pharmaceutical
Forest Pharmaceuticals, a unit of Forest Laboratories (NYSE: FRX), has entered into a plea agreement in which the company accepted responsibility for criminal actions including distribution of an unapproved new drug, distribution of a misbranded drug and obstruction of a Food and Drug Administration inspection. 16 September 2010
Pharmaceutical
The US Federal District Court has ruled in favor of Danish drugmaker H Lundbeck (LUND: DC) and found no violation of the antitrust laws in the company's acquisition of NeoProfen (ibuprofen lysine) Injection (10mg/mL), a drug used in premature infants with patent ductus arteriosus (PDA), a condition in which a blood vessel in the heart fails to close after birth. 13 September 2010
Pharmaceutical
In order to comply with US anti-trust requirements imposed by the Federal Trade Commission to complete its purchase of eye-care specialist Alcon (ACL), Swiss drug major Novartis (NOVN.VX, NVS) was told it had to make certain divestments (The Pharma Letter August 17), one of which was to sell its ophthalmic drug Miochol-E to Bausch & Lomb (NYSE: BOL), a competitor in the eye-care sector. 7 September 2010
Pharmaceutical
A recent report issued by Morgan Stanley, titled Pharmaceuticals - Potential Selective Upside for Industry post Prandin Ruling, predicts 'increasing probability for the innovative pharmaceutical industry to successfully delay US generic approval of select innovative drugs' following a pair of rulings in Novo Nordisk A/S (NVO.N) versus Caraco Pharmaceutical Laboratories, handed down earlier this year by the US Court of Appeals for the Federal Circuit concerning Patent Use Codes (PUCs; The Pharma Letter July 12) and the Danish drugmaker's product Prandin (repaglinide) tablets. 7 September 2010
Pharmaceutical
US drug giant Merck & Co (NYSE; MRK) and Canada-based partner Cardiome Pharma (Nasdaq: CRME/TSX: COM) say that their the formulation of Brinavess (vernakalant) has been granted marketing approval in the European Union, Iceland and Norway for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults. 2 September 2010
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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