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.
Mylan has agreed to divest the rights and assets related to two generic pharmaceutical products to settle US Federal Trade Commission charges that its proposed $7.2 billion acquisition of Swedish drugmaker Meda would be anti-competitive. 29 July 2016
USA-based Vivus says it has filed a lawsuit in the US District Court for the District of New Jersey against Hetero USA Inc and Hetero Labs, units of Indian generics drugmaker Hetero. 28 July 2016
The US Federal Trade Commission (FTC) has approved Teva Pharmaceutical Industries’ takeover of the generics arm of Ireland-incorporated Allergan – subject to the Israeli company’s divestment of dozens of generic drugs. 28 July 2016
Indian drugmaker Dr Reddy’s Laboratories today announced its consolidated financial results for the first fiscal quarter ended June 30, 2016/2017 showing sharp declines in sales and profit margin. 27 July 2016
The European Medicines Agency has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, a contract research organization (CRO) with an analytical and a clinical site located in Bangalore, India. 24 July 2016
Israeli generics giant Teva Pharmaceutical Industries has attracted more than 30 billion euros ($33.04) of orders for a four billion euros bond sale in Europe. 22 July 2016
Privately-held USA-based Citron Pharma has launched a generic version of AstraZeneca's cholesterol drug Crestor (rosuvastatin calcium) tablets in the USA. 22 July 2016
Ireland-incorporated Perrigo has announced that Douglas Boothe, the general manager of its Rx Pharmaceuticals segment, is leaving the company. 21 July 2016
California, USA-based Koios Pharmaceuticals announced that it has filed a challenge to the validity of US Patent 8,644,231, the sole Orange-Book listed patent protecting Rasuvo - a methotrexate autoinjector product marketed by the US subsidiary of privately-held German firm medac GmbH - from generic competition. 21 July 2016
The European Commission has approved under the EU Merger Regulation the proposed $7.2 billion acquisition of Sweden’s Meda by Netherlands-incorporated drugmaker Mylan, subject to conditions. 21 July 2016
Jordan-headquartered Hikma Pharmaceuticals has launched capecitabine tablets 150mg and 500mg, the generic equivalents to Xeloda, through its affiliate West-Ward Pharmaceuticals. 20 July 2016
Sun Pharma Advanced Research Company and India’s largest drugmaker Sun Pharma have entered into a licensing arrangement for SPARC’s Elepsia XR (levetiracetam extended release tablets) for the US market. 20 July 2016
Israeli drugmaker Teva Pharmaceutical Industries placed $15 billion of debt on sale on Monday to finance its $40.5 purchase of the generics business of Ireland-incorporated Allergan. 19 July 2016
US generic drugmaker ANI Pharmaceuticals today revealed that it has received approval from the US Food and Drug Administration of the Abbreviated New Drug Application for nilutamide tablets. 18 July 2016
Sun Pharmaceutical Industries has rolled out InfuSMART the first ever ready to administer version of anti-cancer drug gemcitabine in six countries. 15 July 2016
Teva Pharmaceutical Industries will raise between $20 billion and $25 billion in a multi-currency bond sale to pay for its $40.5 billion acquisition of the generics business of Ireland-incorporated company Allergan. 15 July 2016
Pfizer and NovaMedica, a company established by Russian high-technology investment fund Rusnano and American venture health care fund Domain Associates in 2012, have entered into an agreement to cooperate. 14 July 2016
AstraZeneca has reached an agreement with Sandoz, a division of Swiss pharma giant Novartis, over the US development of a generic version of the breast cancer drug Faslodex (fulvestant). 14 July 2016
The US Food and Drug Administration has issued two draft guidance documents describing how the FDA would implement provisions of federal law that restrict compounding human drug products that are essentially copies of commercially available or approved drug products. 8 July 2016
Reports have linked Indian drugmaker Aurobindo to buying European assets of Israeli generics giant Teva Pharmaceutical Industries, with talk of a deal worth as much as $1.5 billion. 7 July 2016
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
Sign up to receive email updates Join industry leaders for a daily roundup of biotech & pharma news
Company Spotlight
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.