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Generics
Following a public comment period, the US Federal Trade Commission has approved a final order settleing charges that privately-held Amneal Pharmaceutical’s $1.45 billion acquisition of an equity share in Impax Laboratories likely would be anticompetitive. 11 July 2018
Generics
The US District Court for the District of New Jersey heard UK-incorporated Indivior's application for a preliminary injunction (PI) against India’s Dr Reddy's Laboratories (DRL). 30 June 2018
Generics
Following the announcement a day earlier that Indian generic drugmaker Dr Reddy’s Laboratories had received US approval for a copy cat version of its Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence, and launched the product on Friday - despite ongoing litigation, Indivior on Saturday announced that the US District Court for the District of New Jersey has granted Indivior a temporary restraining order (TRO) that compels Dr Reddy's to immediately cease its launch activities related to Suboxone Film. 16 June 2018
Generics
Following marketing approval on February 18 and listing in the National Health Insurance (NHI) reimbursement price list, Daiichi Sankyo (TYO: 4568) says it has launched fentanyl citrate tape in Japan today. 15 June 2018
Generics
US Senator Orrin Hatch (Republican, Utah), the Chairman of the Senate Republican High-Tech Task Force and co-author of the Hatch-Waxman Act, at the Senate Judiciary Committee hearing, said that he has filed an amendment, the Hatch-Waxman Integrity Act of 2018, to restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development. 15 June 2018
Generics
Mylan shares fell 4.3% to $39.90 in after-hours trading yesterday, after the company revealed it has received an update from the US Food and Drug Administration concerning its pending approval for generic Advair Diskus (fluticasone/salmeterol) that FDA has identified minor deficiencies to be relayed in a Complete Response Letter on June 27, 2018. 14 June 2018
Generics
Upsher-Smith Laboratories today announced that it has entered into an exclusive agreement with a pharmaceutical partner to market and distribute a group of six ophthalmic and otic Abbreviated New Drug Application (ANDA) products with combined annual sales of more than $1.6 billion (IQVIA, 12 months ending March 2018). 1 June 2018
Generics
The Full Court of the Federal Court of Australia has dismissed an appeal by the Australian Competition and Consumer Commission (ACCC) against an earlier judgment in relation to Pfizer Australia. 28 May 2018
Generics
UK-based Indivior and its US subsidiary have entered into a settlement agreement with Par Pharmaceutical and its affiliates resolving patent litigation related to Suboxone (buprenorphine and naloxone) Sublingual Film, which is used is used in the treatment of opioid addiction. 15 May 2018
Generics
The US Association for Accessible Medicines (AAM) believes that all finished pharmaceuticals, pharmaceutical ingredients and active pharmaceutical ingredients (API) should be removed from the annex of products to be subject to additional duties published in US Trade Representative’s (USTR) 301 Notice. 15 May 2018
Generics
Pharma Research Products Company, a South Korean publicly-listed firm engaged in the development of medical aesthetic products, announced that it has secured majority ownership of botulinum toxin type A injection (ReNtox) production facility of BioCND, a South Korean venture company. 14 May 2018
Generics
China has removed import duties on as many as 28 medicines, including all cancer drugs, from May 1, a move which would help India to export these pharmaceuticals to the neighboring country, according to The Times of India and other local media. 7 May 2018
Generics
Amneal Pharmaceuticals has announced the launch of its generic equivalent to Lundbeck's Sabril (vigabatrin) in the USA. 2 May 2018
Generics
Chinese research and development platform company WuXi AppTec subsidiary STA Pharmaceuticals has signed an investment agreement with the government of Shanghai, Jinshan District to build a new R&D center. 27 April 2018
Generics
Japanese drugmaker Ohara Pharmaceutical has reduced the price of its generic drug for leukemia to about half the price of the generic drugs sold by its competitors to encourage leukemia patients to use more affordable medication, according to the Yomiuri Shimbun. 13 April 2018
Generics
US District Court Judge Leonard Stark in Wilmington, Delaware, on Wednesday overturned a US jury’s verdict, releasing Israeli generics giant Teva Pharmaceutical Industries from a $235 million verdict over its generic version of GlaxoSmithKline blood pressure drug Coreg (carvedilol). 29 March 2018
Generics
Impax Laboratories announced that at its special meeting of stockholders, Impax stockholders overwhelmingly approved the previously announced business combination of Impax with privately-held Amneal Pharmaceuticals. 28 March 2018
Generics
The US Food and Drug Administration yesterday posted new quarterly activity metrics for the Generic Drugs Program. 15 March 2018
Generics
The European Commission on Friday published its eighth monitoring report on pharmaceutical patent settlements. 10 March 2018
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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