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Member companies in the Association of Innovative Pharmaceutical Industry (AIFP) and the Czech Association of Pharmaceutical Companies (CAFF) have pointed out the illegality of the abolition of the suspensory effect of appeals against administrative decisions, as proposed by the Ministry of Health as part of the planned short-term savings on drug expenditures. 13 July 2011
Biotechnology
The Second Judicial District Court of US state Nevada ruled in favor of PD BioPharma (Nasdaq: PDLI) on two motions filed by Genentech and its parent company, Swiss drug major Roche (ROG: SIX), in PDL's royalty law suit related to a 2003 settlement agreement with Genentech. PDL's stock rose 9.2% to $6.28 on the news yesterday. 12 July 2011
Generics
Hearings of the constitutional case challenging the implementation of the Kenya Anti-Counterfeit Act, which was proposed in 2008 and enacted in mid-2010, has been adjourned to September 26, 2011. In Kenya, it is estimated that around 30% of drugs on the market are fakes. 10 July 2011
Generics
The European Commission's second monitoring exercise of patent settlements in the pharmaceutical sector shows a continuing decline of settlements potentially problematic under European Union antitrust rules. 7 July 2011
Pharmaceutical
The European Commission has closed an antitrust investigation into allegations by Spain's largest drugmaker Almirall (ALM: MC) that independent German pharmaceutical company Boehringer Ingelheim had filed for unmeritous patents regarding new treatments of chronic obstructive pulmonary disease (COPD). 7 July 2011
Generics
Ireland-headquartered drugmaker Shire (LSE: SHP) says it has filed law suits in the US District Court for the District of New Jersey against each of privately-held US generic drugmaker Amneal Pharmaceuticals and Sandoz Inc, the US generics subsidiary of Swiss drug major Novartis (NOVN: VX) for infringement of certain of Shire's attention-deficit hyperactivity disorder (ADHA) treatment Vyvanse (lisdexamfetamine dimesylate) patents. 5 July 2011
Biotechnology
Europe's largest biotech firm Actelion (SIX: ATLN) revealed yesterday that it may report an operating loss, because, in the absence of a judgment in regard to the law suit with Japanese drugmaker Asahi Kasei Pharma (case number CIV 478533, Superior Court of the State of California, County of San Mateo, USA), the company will make a provision for the full award of damages announced last month. 30 June 2011
Generics
The US House of Representatives last week passed HR 1249, the Leahy-Smith America Invents Act, with broad bipartisan support. The Senate passed its version of the bill (S 23) on March 8 by a vote of 95 to 5. The two chambers will now work out differences between the bills and then a final vote on a compromise bill will have to take place (likely in the Senate). 27 June 2011
Generics
There were victories for both the branded prescription and generic drugmakers in the USA yesterday, as the US Supreme Court handed out verdicts on two cases that impact their operations. The court ruled by a narrow margin of five to four that generic drugmakers are immune from state law suits for failure to warn consumers about possible side effects as long as they copy the warnings that are presented on originator brand-name drugs. 24 June 2011
Pharmaceutical
UK drugs giant GlaxoSmithKline (LSE: GSK) has agreed to pay $40.75 million, which will be divided among 37 US states and the District of Columbia, as part of an agreement reached related to events during the early 2000s at its former manufacturing facility in Cidra, Puerto Rico. 24 June 2011
Generics
US drugmaker Watson Pharmaceuticals (NYSE: WPI) confirmed on Friday that the US District Court for the District of Nevada denied a request from Duramed Pharmaceuticals, a subsidiary of Israeli generics giant Teva Pharmaceutical Industries (Nasdaq: TEVA), for a preliminary injunction and request for a temporary restraining order preventing Watson's launch of a generic version of the contraceptive Seasonique (levonorgestrel/ethinyl estradiol and ethinyl estradiol. Teva's shares fell 4% to 163.80 shekels on the news. 20 June 2011
Pharmaceutical
A law suit has been filed against US health care major Abbott Laboratories (NYSE: ABT) in a US federal court claiming the firm's blockbuster rheumatoid arthritis drug, Humira (adalimumab, also sold by Japan's Eisai), caused a fungal infection resulting in the near-death of a Tennessee man. 14 June 2011
Biotechnology
US biopharmaceutical company Gilead Sciences (Nasdaq: GILD) revealed late Friday that it has received a subpoena from the UDS Attorney's Office for the Northern District of California requesting documents related to the manufacture, and related quality and distribution practices of its leading and investigational HIV/AIDS drugs as well as other products. News of the subpoena saw the firm's shares drop 2.4% to $39.25 in after-hours trading that day. 13 June 2011
Pharmaceutical
The US subsidiary of Belgian pharmaceutical manufacturer UCB SA (Euronext Brussels: UCB) last week pleaded guilty to the off-label promotion of its epilepsy drug Keppra (levetiracetam) and will pay more than $34 million to resolve criminal and civil liability arising out of its illegal conduct, the Department of Justice announced. 13 June 2011
Pharmaceutical
It was a good news day for US drug major Eli Lilly (NYSE: LLY) yesterday, as the firm received approval for new labeling for its Humalog (insulin lispro injection [rDNA origin]), and the US District Court for the Southern District of California ruled in Lilly's favor, vacating a temporary restraining order and denying a request by Amylin Pharmaceuticals (Nasdaq: AMLN) for a preliminary injunction that sought to impose restrictions on the Lilly Diabetes sales force and other relief. Amylin recently filed litigation involving the two companies' diabetes collaboration agreement (The Pharma Letter May 27). 9 June 2011
Biotechnology
France's BioAlliance Pharma (Euronext Paris: BIO) has filed an appeal to the French Supreme Court contesting a preliminary procedural decision on jurisdiction in the arbitration against Dutch drugmaker SpePharm Holdings and their joint venture SpeBio. The proceedings to the arbitral tribunal are still at a preliminary stage concerning the scope of its jurisdiction. This tribunal will have to rule on the relief sought by BioAlliance Pharma and the counterclaims of SpePharm and SpeBio. 8 June 2011
Pharmaceutical
Civil penalties amounting to just over $327 million have been announced in the case of State of South Carolina versus Ortho-McNeil-Janssen Pharmaceuticals and parent company Johnson & Johnson (NYSE: JNJ), where the judge rule that they deceptively marketed the anti-psychotic drug Risperdal (risperidone) deceptively. 6 June 2011
Generics
Last week, in a seven-page response, the US Food and Drug Administration denied an October 18, 2010 Citizen Petition submitted on behalf of Indian drugmaker Lupin (LOPN: BO requesting that FDA determine that Teva Pharmaceuticals USA, a unit of Israeli generics giant Teva Pharmaceutical Industries (Nasdaq: TEVA) Abbreviated New Drug Application No 79-081 for a generic version of Combivir (lamivudine and zidovudine) capsules, and that contains the first Paragraph IV certification to an Orange Book-listed patent on the Reference Listed Drug (RLD), is not eligible for 180-day exclusivity. 3 June 2011
Generics
Israeli generics giant Teva Pharmaceutical Industries (Nasdaq: TEVA) announced yesterday that patent litigation with global drugs behemoth Pfizer (NYSE: PFE) related to generic versions of Pfizer's Neurontin (gabapentin) capsules and tablets sold by Teva and its subsidiary IVAX Pharmaceuticals has been dismissed by the US District Court for the District of New Jersey pursuant to a settlement between the parties, which provides for a full release of Teva and its subsidiaries. The financial terms of the settlement are confidential. 1 June 2011
Pharmaceutical
The European Union Council on Friday formally adopted new legislation aimed at protecting patients against the rising threat of falsified medicines. The new EU law is a major step forward in fighting falsified medicines in the region, the Council stated. 31 May 2011
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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