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Pharmaceutical
US pharma major AbbVie has filed a lawsuit seeking to narrow the definition of a “340B patient,” opening a new legal front in a long-running dispute over the US drug discount program. 9 April 2026
Pharmaceutical
A US appeals court has reinstated a whistleblower lawsuit accusing AbbVie, AstraZeneca, Novartis and Sanofi of inflating drug prices under a key federal discount program, reopening a potentially costly legal battle over industry pricing practices. 18 March 2026
Pharmaceutical
A federal judge has put the brakes on changes to the USA’s childhood vaccine schedule made by Health and Human Services (HHS) Secretary Robert F Kennedy Jr (RFK Jr). 17 March 2026
Biotechnology
Roivant announced that its subsidiary Genevant Sciences and Arbutus Biopharma have entered into a $2.25 billion global settlement with Moderna to resolve all US and international enforcement actions involving Moderna’s unauthorized use of Genevant’s and Arbutus’ LNP delivery technology in its COVID-19 vaccines, including Spikevax. 4 March 2026
Pharmaceutical
A coalition of 15 states has sued US Health and Human Services Secretary Robert F Kennedy Jr and senior federal health officials, seeking to block what they call a sweeping rewrite of the nation’s childhood immunization schedule. 26 February 2026
Generics
In a major boost for India’s generics industry, the Delhi High Court has ruled that Macleods Pharmaceuticals may continue its petition to revoke a patent held by German drugmaker Boehringer Ingelheim, even though the patent has already expired. 26 February 2026
Biosimilars
South Korea’s Samsung Bioepis has signed a settlement and license agreement with US biotech Regeneron concerning the commercialization of Opuviz (aflibercept-yszy), a biosimilar to Eylea 2mg (aflibercept), in the USA, following an earlier settlement covering Europe and the Rest of the World (RoW). 12 February 2026
Pharmaceutical
Danish pharma major Novo Nordisk today announced that it has now filed a previously threatened lawsuit against telehealth company Hims & Hers, for infringing US Patent 8,129,343 with Hims’ compounded semaglutide products for the US market. 10 February 2026
Pharmaceutical
The US Department of Health and Human Services has agreed to abandon a proposed rebate-based pilot for the 340B drug pricing program, marking a clear win for hospital groups that argued the scheme would strain safety-net providers serving low-income patients. 9 February 2026
Generics
Danish drugmaker's Novo Nordisk’s shares fell more than 8% on Thursday after Hims & Hers announced that it would be releasing a compounded version of its oral GLP-1 agonist Wegovy (semaglutide), a weight-loss pill with a $49-a-month introductory price. 6 February 2026
Generics
A group of 42 US states and territories has filed a fresh antitrust lawsuit accusing Swiss pharma Novartis and its former generics unit Sandoz of colluding to fix prices and allocate markets for generic medicines over several years. 4 February 2026
Pharmaceutical
The US Department of Health and Human Services (HHS) has issued new guidance clarifying when direct-to-consumer (DTC) drug sales are unlikely to breach the federal anti-kickback statute, as more biopharmas roll out cash-pay models and ahead of the planned TrumpRx portal launch. 29 January 2026
Generics
In a significant ruling for pharmaceutical regulation in India, the Delhi High Court has reinstated the Indian government's ban on two fixed-dose combination (FDC) drugs prescribed for type 2 diabetes. 27 January 2026
Biotechnology
US healthcare company Sagebrush Health Services, a non-profit organization serving more than 10,000 Nevada patients, has filed a lawsuit against Amgen. 22 January 2026
Pharmaceutical
French drugmaker Ipsen announced that the Arbitral Tribunal of the International Chamber of Commerce (ICC) has issued a final decision in favor of Ipsen, dismissing the claim initiated by Galderma in the arbitration proceedings related to Ipsen’s termination of the R&D agreement. 22 January 2026
Biosimilars
Iceland-based biosimilars developer Alvotech and a US affiliate of Israel’s Teva Pharmaceutical Industries, today announced that they have reached a settlement and license agreement with Regeneron Pharmaceuticals concerning the launch of AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept) in the USA. 19 December 2025
Biotechnology
A German court has ordered Merck & Co to halt launch preparations for its new subcutaneous version of Keytruda (pembrolizumab) in the country, handing Halozyme Therapeutics an early advantage in a widening patent dispute over injectable delivery technology. The ruling follows Halozyme’s request for urgent relief. 8 December 2025
Biotechnology
On December 2, the US Court of Appeals for the Federal Circuit (the Federal Circuit) reversed a decision from the US District Court for the Eastern District of Texas that found Pfizer subsidiary Seagen’s US Patent No 10,808,039 (the ’039 patent) not invalid (the Texas decision). 5 December 2025
Pharmaceutical
The US District Court for the District of Columbia has rejected Israel-headquartered Teva Pharmaceuticals Industries’ challenge to the Medicare Drug Price Negotiation Program - marking the 16th defeat against the industry’s nationwide legal campaign to prevent the law from lowering prices. 24 November 2025
Biotechnology
Shares of AnaptysBio fell 14% in pre-market trading on Friday after the US drug developer and Tesaro, a unit of UK pharma major GSK, filed lawsuits against each other, with both claiming a breach in a partnership deal for a cancer drug. 21 November 2025
Pharmaceutical
US pharma major AbbVie has filed a lawsuit seeking to narrow the definition of a “340B patient,” opening a new legal front in a long-running dispute over the US drug discount program. 9 April 2026
Pharmaceutical
A US appeals court has reinstated a whistleblower lawsuit accusing AbbVie, AstraZeneca, Novartis and Sanofi of inflating drug prices under a key federal discount program, reopening a potentially costly legal battle over industry pricing practices. 18 March 2026
Pharmaceutical
A federal judge has put the brakes on changes to the USA’s childhood vaccine schedule made by Health and Human Services (HHS) Secretary Robert F Kennedy Jr (RFK Jr). 17 March 2026
Biotechnology
Roivant announced that its subsidiary Genevant Sciences and Arbutus Biopharma have entered into a $2.25 billion global settlement with Moderna to resolve all US and international enforcement actions involving Moderna’s unauthorized use of Genevant’s and Arbutus’ LNP delivery technology in its COVID-19 vaccines, including Spikevax. 4 March 2026
Pharmaceutical
A coalition of 15 states has sued US Health and Human Services Secretary Robert F Kennedy Jr and senior federal health officials, seeking to block what they call a sweeping rewrite of the nation’s childhood immunization schedule. 26 February 2026
Generics
In a major boost for India’s generics industry, the Delhi High Court has ruled that Macleods Pharmaceuticals may continue its petition to revoke a patent held by German drugmaker Boehringer Ingelheim, even though the patent has already expired. 26 February 2026
Biosimilars
South Korea’s Samsung Bioepis has signed a settlement and license agreement with US biotech Regeneron concerning the commercialization of Opuviz (aflibercept-yszy), a biosimilar to Eylea 2mg (aflibercept), in the USA, following an earlier settlement covering Europe and the Rest of the World (RoW). 12 February 2026
Pharmaceutical
Danish pharma major Novo Nordisk today announced that it has now filed a previously threatened lawsuit against telehealth company Hims & Hers, for infringing US Patent 8,129,343 with Hims’ compounded semaglutide products for the US market. 10 February 2026
Pharmaceutical
The US Department of Health and Human Services has agreed to abandon a proposed rebate-based pilot for the 340B drug pricing program, marking a clear win for hospital groups that argued the scheme would strain safety-net providers serving low-income patients. 9 February 2026
Generics
Danish drugmaker's Novo Nordisk’s shares fell more than 8% on Thursday after Hims & Hers announced that it would be releasing a compounded version of its oral GLP-1 agonist Wegovy (semaglutide), a weight-loss pill with a $49-a-month introductory price. 6 February 2026
Generics
A group of 42 US states and territories has filed a fresh antitrust lawsuit accusing Swiss pharma Novartis and its former generics unit Sandoz of colluding to fix prices and allocate markets for generic medicines over several years. 4 February 2026
Pharmaceutical
The US Department of Health and Human Services (HHS) has issued new guidance clarifying when direct-to-consumer (DTC) drug sales are unlikely to breach the federal anti-kickback statute, as more biopharmas roll out cash-pay models and ahead of the planned TrumpRx portal launch. 29 January 2026
Generics
In a significant ruling for pharmaceutical regulation in India, the Delhi High Court has reinstated the Indian government's ban on two fixed-dose combination (FDC) drugs prescribed for type 2 diabetes. 27 January 2026
Biotechnology
US healthcare company Sagebrush Health Services, a non-profit organization serving more than 10,000 Nevada patients, has filed a lawsuit against Amgen. 22 January 2026
Pharmaceutical
French drugmaker Ipsen announced that the Arbitral Tribunal of the International Chamber of Commerce (ICC) has issued a final decision in favor of Ipsen, dismissing the claim initiated by Galderma in the arbitration proceedings related to Ipsen’s termination of the R&D agreement. 22 January 2026
Biosimilars
Iceland-based biosimilars developer Alvotech and a US affiliate of Israel’s Teva Pharmaceutical Industries, today announced that they have reached a settlement and license agreement with Regeneron Pharmaceuticals concerning the launch of AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept) in the USA. 19 December 2025
Biotechnology
A German court has ordered Merck & Co to halt launch preparations for its new subcutaneous version of Keytruda (pembrolizumab) in the country, handing Halozyme Therapeutics an early advantage in a widening patent dispute over injectable delivery technology. The ruling follows Halozyme’s request for urgent relief. 8 December 2025
Biotechnology
On December 2, the US Court of Appeals for the Federal Circuit (the Federal Circuit) reversed a decision from the US District Court for the Eastern District of Texas that found Pfizer subsidiary Seagen’s US Patent No 10,808,039 (the ’039 patent) not invalid (the Texas decision). 5 December 2025
Pharmaceutical
The US District Court for the District of Columbia has rejected Israel-headquartered Teva Pharmaceuticals Industries’ challenge to the Medicare Drug Price Negotiation Program - marking the 16th defeat against the industry’s nationwide legal campaign to prevent the law from lowering prices. 24 November 2025
Biotechnology
Shares of AnaptysBio fell 14% in pre-market trading on Friday after the US drug developer and Tesaro, a unit of UK pharma major GSK, filed lawsuits against each other, with both claiming a breach in a partnership deal for a cancer drug. 21 November 2025
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