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Generics
Fresenius Kabi yesterday announced the availability in the USA of Ertapenem for Injection in a 1 gram vial presentation. 12 December 2019
Generics
Fresenius Kabi has announced the immediate availability in the USA of Fosaprepitant for Injection 150mg per vial, the newest addition to the company’s generic oncology portfolio. 14 November 2019
Generics
The US Food and Drug Administration issued a statement1 on Friday, November 1, providing an update with the latest information on ranitidine. 4 November 2019
Generics
Anglo-Swedish drugmaker AstraZeneca has agreed the sale and licence of the commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in Europe and Russia to Germany’s Cheplapharm Arzneimittel. 30 October 2019
Generics
Allergan’s Forest Laboratories subsidiaries have agreed to pay $750 million to settle a lawsuit over Namenda (memantine), an off-patent treatment for moderate-to-severe dementia associated with Alzheimer's disease. 29 October 2019
Generics
China's national health commission has issued a list of 34 drugs for which it urges generics from Chinese companies. 10 October 2019
Generics
The Novartis generics unit Sandoz has welcomed a UK court ruling that allows it to continue to market its AirFluSal Forspiro inhaler in the country. 4 October 2019
Generics
Dr Carlo de Notaristefani, executive vice president, global operations, will retire from Teva Pharmaceutical Industries. 2 October 2019
Generics
India drugmaker Lupin Limited has announced the appointment of Jon Stelzmiller as the president of its US Specialty business. 26 September 2019
Generics
Christoph Stoller was today elected as president of Medicines for Europe for a two-year period. 25 September 2019
Generics
Withdrawal requests for (parallel) marketing authorizations per December 31, the so-called 'year-end withdrawals' for medicines for human use, must be received by the Medicines Evaluation Board (MEB) on November 1, 2019, at the latest, in order to be completed in time. 23 September 2019
Generics
Indian firm MSN Labs has won US approval for its generic injectables decitabine and fosaprepitant, through its American subsidiary Novadoz Pharmaceuticals. 6 September 2019
Generics
Endo International says that partner Novitium Pharma has received approval from the US Food and Drug Administration for a room temperature stable, AB-rated, generic equivalent of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules). 4 September 2019
Generics
Endo International announced today that one of its operating companies, Par Pharmaceutical, has begun shipping an authorized generic version of Merck & Co's antifungal agent Noxafil (posaconazole) delayed-release tablets, 100mg. 3 September 2019
Generics
Ajinomoto Bio-Pharma Services, a provider of biopharmaceutical contract development and manufacturing services, announced today its intention to purchase the remaining 50% ownership interest in its Visakhapatnam, India joint venture, Granules OmniChem Private from its joint venture partner, Granules India Limited. 29 August 2019
Generics
Israeli generics giant Teva Pharmaceutical Industries has launched a copy of Mylan’s EpiPen Jr (epinephrine injection, USP) auto-injector in the USA. 20 August 2019
Generics
Indian drugmaker Torrent Pharma has been told by the US Food and Drug Administration (FDA) that the inspection carried out at the company’s Indrad facility in April has been classified as Official Action Initiated. 14 August 2019
Generics
A subsidiary of China-based manufacturer Nanjing King-Friend Biochemical Pharmaceutical Company (NKF) has agreed to take an increased stake in US generic injectables company Meitheal Pharmaceuticals for $95 million. 13 August 2019
Generics
Indian pharma major Lupin Limited has announced the completion of the Good Manufacturing Practices (GMP) Inspection of its finished product manufacturing facility (Unit-1) at Mandideep, by the French National Agency for Medicines and Health Products Safety (ANSM). 7 August 2019
Generics
Indian pharma major Lupin today announced the receipt of the Establishment Inspection Report (EIR) from the US Food and Drug Administration for its Aurangabad facility. 5 August 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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