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Biotechnology
As soon as US biotech giant Amgen announced that it is to acquire Horizon Therapeutics in a deal worth $27.8 billion, concerns were voiced that the US competition regulator would take a serious look at monopoly and anti-competitiveness implications. 16 May 2023
Biotechnology
US biotech major Gilead Sciences has prevailed in a legal battle with its country’s government over HIV pre-exposure prophylaxis (PrEP) patents. 10 May 2023
Pharmaceutical
The life sciences industry has always been subjected to transparency requirements. To help avoid compliance violations that may lead to penalties, many life science organizations have ramped up their efforts to collect compliance data and streamline the reporting process. 10 May 2023
Generics
Two Indian pharma companies have reached a mutual settlement with Bristol Myers Squibb in connection with a patent dispute over BMS' oral anticoagulant drug apixaban, even as the Delhi High Court has dismissed BMS' another request for an injunction against Zee Laboratories. 2 May 2023
Pharmaceutical
The US Supreme Court preserved access to a widely-used abortion medication Friday evening. 24 April 2023
Biotechnology
Danish biotech Genmab today announced an award in the second arbitration relating to its license agreement with Janssen Biotech. 21 April 2023
Pharmaceutical
The next legal battleground for the abortion pill mifepristone will be in the US Supreme Court. 14 April 2023
Pharmaceutical
The US Biotechnology Innovation Organization (BIO) has signed onto an amicus brief to challenge a District Court’s unprecedented ruling (related to the ‘morning after’ abortion pill mifepristone (marketed under the trade name Mifeprex) that would create regulatory barriers and potentially upend the US Food and Drug Administration’s (FDA) authority to approve life-saving and life-enhancing therapies to patients. 13 April 2023
Pharmaceutical
India’s Delhi High Court has refused to grant an interim injunction to German family-owned pharma major Boehringer Ingelheim in patent litigation concerning its patent-protected diabetes drug linagliptin, which is marketed under the brand names Trajenta and Trajenta Duo. 12 April 2023
Pharmaceutical
A Texas federal judge on Friday ruled that the US Food and Drug Administration (FDA) "stonewalled judicial review" of its decades-old approval of the ‘morning after’ abortion pill mifepristone (marketed by Danco Laboratories under the trade name Mifeprex) and agreed to stay the effective date of the drug's approval. 11 April 2023
Pharmaceutical
The Indian patent office has rejected US healthcare giant Johnson & Johnson's secondary patent on the tuberculosis (TB) med bedaquiline. 31 March 2023
Pharmaceutical
Shares in UK pharma major GSK closed 3% lower on Friday. 27 March 2023
Biotechnology
US biotech Moderna has failed to dodge a patent lawsuit relating to its COVID-19 vaccine. 13 March 2023
Biotechnology
US biotech Gilead Sciences has now been awarded damages totalling nearly a quarter of a billion dollars in a case that the drugmaker filed against several healthcare clinics, pharmacies, prescribers, and lab testing facilities. 10 March 2023
Biotechnology
A judge in the USA has dismissed litigation against Bristol Myers Squibb, alleging the New York-based company defrauded former Celgene shareholders out of $6.4 billion. 3 March 2023
Generics
Patients in India suffering from cystic fibrosis are petitioning the Indian government to allow generic versions of Vertex Pharmaceuticals’ (Nasdaq: VRTX) Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) and Orkambi (lumacaftor/ivacaftor). 17 February 2023
Generics
Indian drugmaker Glenmark Pharmaceuticals (BSE: 532296) and US pharma giant Merck & Co (NYSE: MRK) are facing an antitrust lawsuit over allegations that the duo illegally settled a patent dispute in order to delay the launch of generic versions of the blockbuster cholesterol reducer Zetia (ezetimibe). 16 February 2023
Pharmaceutical
Leaked proposals for the European Commission’s (EC) Pharmaceutical Review package have angered an industry group. 13 February 2023
Generics
The courts in India have come down heavily against certain domestic pharmaceutical companies who have been accused of allegedly flagrantly violating patent policies, with many launching drugs that are still covered by patents, reports The Pharma Letter’s India correspondent. 11 February 2023
Pharmaceutical
Pharma companies participating in the 340B drug pricing program in the USA do not have to provide medicines ad nauseam to contract pharmacies. 31 January 2023
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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