3 October 2024 F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic.
Indian drugmaker Glenmark Pharmaceuticals has received final approval from the US Food and Drug Administration for its generic nebivolol product. 30 May 2017
The USA’s new Food and Drug Administration Commissioner Scott Gottlieb was in the hot seat last week to defend President Donald Trump's budget plan to the House of Representatives appropriations subcommittee. 30 May 2017
On May 30, 2017 (tomorrow), trade talks will resume for the India-EFTA (European Free Trade Association) free trade agreement (FTA) in Liechtenstein, between India and the EFTA countries of Switzerland, Norway, Iceland and Liechtenstein. 29 May 2017
Even as India’s National Pharmaceutical Pricing Authority (NPPA) has fixed the prices of 31 more drug formulations, in yet another crackdown on prices, India's premier policy formulating agency Niti Aayog has proposed a change in the manner the government should identify drugs to be brought under price control. 26 May 2017
Global drugmakers operating in Russia have called on the country’s government to impose a ban on the registration of generics before the expiration of the patent protection of original drugs. 25 May 2017
Prices for drugs from low and middle-priced segments of the Russian market may increase significantly this year, due to plans of the government to change the scheme of pricing for such categories of drugs, starting from January 1, 2018, reports The Pharma Letter’s local correspondent. 19 May 2017
Chinese drugmaker Shanghai Pharmaceutical has confirmed media reports that it is in discussions with financial investors over a possible bid for German generics drugmaker Stada Arzneimittel. 18 May 2017
Taiwan’s Pharmadax has received approval from the US Food and Drug Administration (FDA) to market a generic equivalent of the anti-psychotic drug Seroquel XR (quetiapine fumarate) at five different strengths. 16 May 2017
South African drugmaker Aspen Pharma has confirmed that the European Commission has opened proceedings to investigate certain actions of Aspen Holdings and certain of its European subsidiaries. 16 May 2017
German generic drugmaker Stada Arzneimittel, the subject of a ~$5.6 billion takeover bid by the private equity groups Bain Capital and Cinven reports that group sales for the first-quarter 2017 increased 14% to 566.3 million euros ($615.6 million). 12 May 2017
Israeli generics giant Teva Pharmaceutical Industries today reported results for the first quarter of 2017, posting revenues of $5.6 billion, a rise of 17%. 11 May 2017
Hikma Pharmaceuticals has revealed receipt of a complete response letter (CRL) from the US Food and Drug Administration in relation to its Abbreviated New Drug Application (ANDA) for VR315, its generic version of Advair Diskus (fluticasone propionate and salmeterol inhalation powder). 11 May 2017
Netherlands-incorporated Mylan has unveiled first quarter 2017 results indicating a 24% increase in revenue compared with the same period a year before. 10 May 2017
The US Court of Appeals for the Federal Circuit has affirmed judgment in favor of Indian drugmaker Zydus Cadila’s US subsidiary holding that its proposed generic version of Lialda (mesalamine) does not infringe US Patent No 6,773,720. 10 May 2017
Doctors and public health groups in India have come up with the suggestion that the government should work for the gradual phasing out of branded drugs in a calibrated manner along with the abolition of differential pricing under different brands to give a push to generic drug prescriptions. 8 May 2017
Generic drugmaker Perrigo lost 5% in its stock-market value on Wednesday, closing at $72.35, amid news of a raid on its corporate offices in relation to the US Department of Justice Antitrust Division investigation into price fixing. 4 May 2017
German generic drugmaker Stada Arzneimittel says it has now received the full offer document for the company’s acquisition that was announced on April 10, which it believes is acceptable. 3 May 2017
The necessity of time reduction for Abbreviated New Drug Application (ANDA) approvals, was addressed by Girish Malhotra, President of Epcot International and CPhI Worldwide Annual Industry Report member, arguing that, if the current approval time can be reduced from 10 months to three months, drug costs will decrease. 26 April 2017
French pharma major Sanofi has added to Mylan’s woes over the Netherlands-incorporated drugmaker’s EpiPen (epinephrine) Auto-Injector device. 25 April 2017
Japanese generics firm Sawai Pharmaceutical has signed an agreement to purchase the generic pharmaceuticals business of privately-held Upsher-Smith, from its parent, ACOVA. 21 April 2017
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
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
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
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
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
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
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
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
A significant drop has been noticed in the prices of active pharmaceutical ingredients (APIs), bringing much-needed relief to the pharmaceutical industry and potentially translating to lower drug costs for consumers. 9 September 2024
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
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
German generics major STADA Arzneimittel today announced that it achieved sales of more than 2 billion euros ($2.23 billion) in the first half of 2024. 28 August 2024
In a major crackdown, the Indian government has imposed an immediate ban on 156 fixed-dose combination (FDC) drugs, including commonly used antibiotics, pain relievers,and multivitamins. 27 August 2024
Swipha, a leading Nigerian pharmaceutical manufacturer, has received prequalification from the World Health Organization (WHO) for its sulfadoxine-pyrimethamine (SP) drug. 21 August 2024
One of the largest pharmaceutical production facilities in the Russian North-West region will soon be built in the city of Pushkino by the local drugmaker Active Component enterprise, The Pharma Letter’s local correspondent reports. 14 August 2024
Even as Novartis (NOVN: VX) is locked in a high-stakes battle with the US Food and Drug Administration (FDA) to protect its blockbuster heart failure drug Entresto (sacubitril and valsartan) from generic competition, generic versions of valsartan are making hay in India 8 August 2024
The Russian Ministry of Health has registered the third Russian generic of the original drug Ozempic (semaglutide) from Danish drugmaker Novo Nordisk. 8 August 2024
US biotech major Biogen is disputing the launch of a Russian generic of Spinraza (nusinersen), a drug, which is used to treat spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent. 7 August 2024
Imports of bulk drugs from China have jumped, potentially undermining India's efforts to boost domestic pharmaceutical manufacturing through its Production Linked Incentive (PLI) scheme. 5 August 2024
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A pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.