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Generics
Ireland-based drugmaker Shire (LSE: SHP) says it has settled all pending litigation with Impax Laboratories (Nasdaq: IPXL) over Shire's supply of an authorized generic version of Adderall XR (mixed amphetamine salts). Shire has been supplying Impax with authorized generic Adderall XR since October 2009 pursuant to a supply agreement between the parties. 10 February 2013
Pharmaceutical
US pharma giant Merck & Co (NYSE: MRK) has received a favorable ruling from the US Court of Appeals for the Federal Circuit (Washington) in its patent dispute with Mylan (Nasdaq: MYL) over its cholesterol lowerers Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin), according to reports by Bloomberg and Reuters. 8 February 2013
Generics
European patients should have quicker access to cheaper "generic" medicines, according to Members of the European Parliament (MEPs) voting on a draft law on Wednesday. The draft rules will require authorities to meet new deadlines and transparency requirements on pricing and reimbursement. This vote gives a positive impulse to the Transparency Directive 2012/0035(COD; The Pharma Letter December 19, 2012) by adopting the text by a large majority in Plenary Session. 7 February 2013
Biotechnology
After more than a year of prodding from the Senate Special Committee on Aging, the USA's federal government took a major step today aimed at exposing potential conflicts of interests between doctors and drug companies. 5 February 2013
Pharmaceutical
Ireland-headquartered drugmaker Shire (LSE: SHP) said on Friday that it has reached an agreement in principle to pay around $57.5 million to resolve the previously disclosed civil investigation into the company's US sales and marketing practices relating to the attention-deficit hyperactivity disorder (ADHA) drugs Adderall XR (mixed amphetamine salts), Vyvanse (lisdexamfetamine) and Daytrana (methylphenidate transdermal system). 4 February 2013
Generics
The US Food and Drug Administration announced today that a federal judge has approved a consent decree of permanent injunction against USA-based Ben Venue Laboratories, a unit of family-owned German drug major Boehringer Ingelheim, and three of its corporate officers for failing to comply with current Good Manufacturing Practice (cGMP) requirements as required by federal law. 3 February 2013
Generics
The European Commission has informed US health care giant Johnson & Johnson (NYSE: JNJ) and Swiss drug major Novartis (NOVN: VX) of its objections regarding an agreement - often called a pay-for-delay deal - concluded between their respective Dutch subsidiaries relating to fentanyl (brand name Duragesic), a strong pain-killer. 1 February 2013
Generics
Global pharma behemoth Pfizer (NYSE: PFE) says that the US District Court for the District of Delaware ruled that its patent covering a method for using sirolimus, the active ingredient in Rapamune, for the inhibition of organ transplant rejection is valid and infringed. 1 February 2013
Pharmaceutical
The European Medicines Agency says it has been formally notified by Swiss drug major Novartis (NOVN: VX) of its decision to withdraw its application for a centralized marketing authorization for the Ruvise (imatinib mesylate, the active ingredient of its cancer drug Glivec/Gleevec), 100mg and 400mg film-coated tablets. It was intended to be used for adults as add-on therapy for the treatment of pulmonary arterial hypertension (PAH). 25 January 2013
Biotechnology
US Senator Chuck Grassley (Republican, Iowa) is urging the White House to finalize the Physician Payments Sunshine Act regulations that will disclose the financial relationships between pharmaceutical and medical device companies and doctors. 23 January 2013
Generics
During the 2012 fiscal year, the number of potentially anticompetitive patent dispute settlements - also termed pay-for-delay deals - between branded and generic drug companies increased significantly compared with FY 2011, jumping from 28 to 40, according to a new US Federal Trade Commission staff report. The study also found that in nearly half of these settlements, branded drugmakers may have used the promise that they would not develop or market an authorized generic (AG) as a payment to stall generic drug firms from marketing a competing product. 21 January 2013
Pharmaceutical
In a ruling issued yesterday, the Court of Justice of the European Union said that Spain has failed to fulfil its obligations under EU law related to the application of a reduced rate of value-added tax to a broader range of goods than provided for under the VAT Directive in the field of pharmaceutical products and medical equipment. 17 January 2013
Pharmaceutical
French drug major Sanofi (Euronext: SAN) has entered into a binding agreement to acquire the animal health division of the Indian company Dosch Pharmaceuticals Private Limited, creating a market entry for its Animal Health division Merial in that country's strategically important and growing animal health sector. 21 December 2012
Generics
The US District Judge Reggie Walton, of the District Court for the District of Columbia, has dismissed the case of Endo Pharmaceuticals (Nasdaq: ENDP) against the US Food and Drug Administration. 21 December 2012
Pharmaceutical
Two US subsidiaries of French drug major Sanofi (Euronext: SAN) have agreed to pay $109 million to resolve allegations that Sanofi US violated the False Claims Act by giving physicians free units of Hyalgan (hyaluronate), a knee injection, in violation of the Anti-Kickback Statute, to induce them to purchase and prescribe the product. 20 December 2012
Biotechnology
US biotech firm Celgene Corp (Nasdaq: CELG) has entered a collaboration with San Francisco-based Sutra Biopharma to design and develop novel antibody drug conjugates (ADCs) and bispecific antibodies for two undisclosed targets and to manufacture a proprietary Celgene antibody. 19 December 2012
Generics
Anglo-Swedish drug major AstraZeneca (LSE: AZ) said on Friday that the US Court of Appeals for the Federal Circuit has upheld the decision of the District Court, District of Delaware, finding that the US substance patent protecting the firm's blockbuster cholesterol drug Crestor (rosuvastatin calcium) (RE37,314 - the '314 patent) is valid and enforceable. 17 December 2012
Pharmaceutical
USA-based Pfizer (NYSE: PFE), the world's largest drugmaker by sales, has agreed to pay $55 million plus interest to resolve allegations that Wyeth (which it acquired in 2009 for $68 billion) illegally introduced and caused the introduction into interstate commerce of a misbranded drug, Protonix (pantoprazole), between February 2000 and June 2001, the US Justice Department announced yesterday. 13 December 2012
Biotechnology
Following the historic vote yesterday in the European Union Parliament to approve the unitary patent regulation, which is intended to lead to one patent and one patent court system for EU member states, EU inventors will soon be able to get a unitary patent at last. 12 December 2012
Generics
The US Supreme Court has agreed to a request by the Federal Trade Commission to look into the practice whereby originator drug companies pay would be generic copiers to to drop their patent challenges in exchange for an arranged date when they can start supply copy products once these have been approved by the Food and Drug Administration, often termed pay-for-delay patent settlements. The FTC estimates such "reverse payment" deals cost US consumers $3.5 billion a year. 10 December 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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