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Generics
Mumbai, India-based Cipla has settled a patent litigation for a generic blood cancer medicine with innovator Celgene, which is now a wholly owned subsidiary of Bristol Myers Squibb. 15 December 2020
Generics
China has approved the country's first generic version of now Bristol Myers Squibb company Celgene's Pomalyst (pomalidomide), an immunomodulator treating multiple myeloma. 12 November 2020
Generics
The US unit of Israel’s Teva Pharmaceutical Industries on Friday announced the availability of the first Food and Drug Administration-approved generic versions of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Atripla (emtricitabine and Tenofovir Disoproxil fumarate) tablets, originated by Gilead Sciences. 3 October 2020
Generics
Sweden’s Orexo has filed a patent infringement action in the US District Court for the District of New Jersey against India’s Sun Pharmaceutical Industries and certain of its subsidiaries. 14 September 2020
Generics
The US Food and Drug administration has announced the availability of a guidance for industry, titled “Control of N-Nitrosamine Impurities in Human Drugs.” 2 September 2020
Generics
Hyderabad, India-based Biological E Limited (BE) has announced the acquisition of Akorn India Limited, a subsidiary of US generics firm Akorn Inc, whose shares tumbled more that 15% to $0.11 following the news. 17 August 2020
Generics
UK-incorporated Mylan today announced that the Drug Controller General of India (DCGI) has approved its remdesivir 100mg/vial for restricted emergency use in India as part of the DCGI's accelerated approval process to address urgent, unmet needs amid the evolving coronavirus 2019 (COVID-19) pandemic. 6 July 2020
Generics
Indian drugmaker Lupin’s US subsidiary is voluntarily recalling metformin hydrochloride extended-release tablets USP, a generic equivalent of Fortamet, 500mg, lot G901203 to the consumer level. 11 June 2020
Generics
China on May 12 initiated bio-equivalence testing for generic injectables, including those are already in the market as well as those that have not filed a New Drug Application (NDA) according to the National Medical Products Administration (NMPA). 15 May 2020
Generics
Aceto, a US virtual manufacturer of specialty materials for life sciences, nutrition, agricultural, and advanced technology end markets and a New Mountain Capital portfolio company, announced its acquisition of UK-based Syntor Fine Chemicals on Friday. 18 April 2020
Generics
Zydus Worldwide DMCC, a wholly-owned subsidiary of Indian generic drugmaker Cadila Healthcare, has received tentative approval from the US Food and Drug Administration to market its generic drug macitentan tablets in the USA. 15 April 2020
Generics
Novartis today announced the mutual agreement with Aurobindo Pharma USA Inc to terminate the agreement to sell the Swiss pharma giant’s Sandoz unit’s US generic oral solids and dermatology businesses to Aurobindo Pharma USA Inc. 2 April 2020
Generics
After a ban of nearly six years, the US Food and Drug Administration has lifted an import alert on Ipca Laboratories' two units in Madhya Pradesh (MP), India, to ensure the supply of chloroquine tablets, considered to be one of the possible treatments for the coronavirus infection. 24 March 2020
Generics
China has approved the country's first generic version of USA-based lung specialist United Therapeutics' Remodulin (treprostinil sodium), a treatment for the rare disease pulmonary hypertension. 19 March 2020
Generics
Novartis’ generics division Sandoz has reached a settlement related to a three-year-long antitrust investigation into the US generic drug industry, concerning misconduct between 2013 and 2015. 3 March 2020
Generics
China’s medicines regulator has granted approval for the country's first generic version of Swiss pharma giant Novartis' hypertension drug Exforge (amlodipine and valsartan). 7 February 2020
Generics
Last week we reported that Russian pharmaceutical company Nanolek was cooperating with Israel’s Teva Pharmaceutical Industries on the production of an active ingredient in Russia. 14 January 2020
Generics
The New Drug Application (NDA) for China's first human papillomavirus (HPV) vaccine has received approval from the National Medical Products Administration (NMPA). 1 January 2020
Generics
China's National Medical Products Administration (NMPA) has issued a bioequivalence comparison guideline for Chinese generic vaccine manufacturers. 24 December 2019
Generics
The US Food and Drug Administration (FDA) has published a new analysis confirming that greater competition among generic drugmakers does drive down prices. 17 December 2019
Generics
Indian drugmaker Aurobindo Pharma has taken on the might of China in terms of Penicillin G pricing, and is doing so by leveraging a fully integrated production process at its new plant. Anticipating the price erosion of Penicillin G, the company has put up an integrated plant from scratch. 10 November 2024
Generics
Indian markets are abuzz with a singular refrain. Donald Trump's Presidency of the United States is set to open new opportunities for India, especially in the pharmaceutical sector. 8 November 2024
Generics
US generic drugmaker Viatris announced robust financial results for the third quarter of 2024, driven by positive momentum against all three pillars of its strategy. The company’s shares shot up 13.5% to $13.18 following the announcement. 8 November 2024
Generics
Teva Pharmaceutical Industries’ shares were up 4% at 7,323 shekels today reported results for the quarter ended September 30, 2024. 6 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
Generics
Swiss biosimilars and generics group Sandoz today reported net sales for the third quarter ended September 30, 2024. 30 October 2024
Generics
Lexicon Pharmaceuticals announced that Viatris has obtained an exclusive license from Lexicon to commercialize sotagliflozin outside of the USA and Europe in all indications. 18 October 2024
Generics
The US Food and Drug Administration (FDA) yesterday published the guidance for industry, “Requests for Reconsideration at the Division Level Under GDUFA.” 17 October 2024
Generics
Swiss generic and biosimilar medicines major Sandoz today announced that it has launched a generic paclitaxel formulation in the USA, the first generic to its reference medicine to be approved by the US Food and Drug Administration (FDA). 11 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
Generics
CMS released a Request for Information (RFI) and a sample list of prescription drugs that the agency preliminarily intends to include under the proposed Medicare $2 Drug List Model. 10 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
Generics
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
Generics
US antivirals giant Gilead Sciences today announced that it has signed non-exclusive, royalty-free voluntary licensing agreements with six generic drugmakers to make and sell generic lenacapavir 2 October 2024
Generics
The US Food and Drug Administration (FDA) yesterday released its fiscal year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report. 2 October 2024
Generics
The number of clinical trials of new drugs in Russia is steadily declining, which could be mainly related with the overall reduction of investment activities in the local pharmaceutical market, reports The Pharma Letter’s local correspondent. 30 September 2024
Generics
The generics and biosimilars trade group, Medicines for Europe, has put out a strong message amid ongoing discussions on a European Union (EU) Critical Medicines Act. 26 September 2024
Generics
The protection of intellectual property (IP) rights of foreign pharmaceutical companies in Russia remains complex situation, according to recent statements by Konstantin Panurovsky, legal director of AstraZeneca’s Russian subsidiary, reports The Pharma Letter’s local correspondent. 13 September 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced revised final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA.” 12 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
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