Glenmark Pharmaceuticals, on Tuesday, said the US drug regulator cleared the company's investigational new drug (IND) application to initiate a first-in-human study of GBR 310, a proposed biosimilar, which will assess its pharmacokinetics in comparison to Novartis anti-asthma biologic XOLAIR or omalizumab in healthy adult volunteers between 18-65 years of age.
As global drug makers are exiting low priority brands, their Indian counterparts are lapping up the opportunity buying established products at perhaps low valuations.
Intas said it is undertaking a detailed analysis on reports of inflammation and has advised doctors to avoid using the product, meant to treat an age-related eye condition, from this specific batch.
Tobramycin inhalation had US sales of USD 133.6 million as on December 2016 according to IMS data.
The company has received final approval from the US Food and Drug Administration (USFDA) for its Tobramycin Inhalation Solution, the Mumbai-based company said in a statement.
Global drug major Novartis has invested, expanded its research & development (R&D) capabilities in India. The global leader in biosimilars through its subsidiary Sandoz is assessing Indian market dynamics to launch its portfolio.
The pan-European Stoxx 600 was 0.65 percent higher with all sectors trading positive.
"When we build a new manufacturing site we think about the tax rate, we think about the economy of the country, we think about jobs, so a booming US economy would make the US more attractive for investment," Joe Jimenez said on Wednesday.
Twenty-two companies, including Pfizer, Merck, Novartis, Roche, Sanofi and GlaxoSmithKline, will contribute funds and expertise to the project, which is backed by the World Bank.
Bengaluru-based biopharmaceutical firm Biocon on Wednesday said US drug regulator has accepted its partners Mylan‘s biologics license application (BLA) for the proposed biosimilar of breast cancer drug Trastuzumab through the 351(k) pathway.
The therapies called AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx have the potential to lower lipoproteins Lp(a) and ApoCIII by up to 90 percent, it said. Novartis has also entered into a stock purchase agreement with Ionis, it added without elaborating.
Selexys specialises in sickle cell disease, an inherited form of anaemia that is most common among people of African descent.
Wockhardt, Sun Pharma, Tara, Novartis and other pharma company Perrigo are also in focus on account of reports from the US that there are lawsuits filed by Unions representing the New York Police Department on price collusion of two dermatology products.
Several firms are reporting earnings Tuesday, including Novartis, Norsk Hydro, Randstand and Swedbank.
"These 14 prescription brands acquired by the company earlier this year will be transferred from Novartis Pharma K.K. to Sun Pharma's subsidiary in Japan beginning October 2016," Sun Pharma said in a statement today.
Andrew Aristidou, CFO and ED Finance, GSK Pharma, speaks about the company‘s new launches and why GSK Pharma is in no rush to delist in India.
Although the world's biggest prescription drugmaker's first-quarter core net income fell 13 percent to USD 2.79 billion, it beat the USD 2.76 billion average of estimates from analysts polled by Reuters and lifted the company's shares.
According to the agreements signed by the parties, a wholly-owned subsidiary of Sun Pharma will acquire the portfolio consisting of 14 established prescription brands from Novartis for a cash consideration of USD 293 million, Sun Pharma said in a statement.
The company's subsidiary has received final approval for Imatinib Mesylate from Food and Drug Administration (FDA) in December 2015.
Gleevec, or imatinib mesylate, costs up to about USD 90,000 annually in the United States, implying Sun's price could be roughly USD 60,000. Gleevec posted USD 4.7 billion in global revenue in 2015, and Swiss-based Novartis has said the US patent expiry puts around USD 2.5 billion in annual sales at risk.
Excluding asset sales net profits at the world's largest pharmaceutical company by sales fell by 5 percent to USD 12 billion, missing expectations of analysts polled by the Swiss financial news agency AWP of an average of USD 12.1 billion.
On the annual Industrial R&D Investment Scoreboard for 2015, prepared by European Commission, Volkswagen is followed by Samsung, Microsoft, Intel and Novartis in the top-five.
Alembic Pharmaceuticals group firm Rhizen Pharmaceuticals SA has entered into an exclusive worldwide license agreement with Novartis for the development and commercialisation of a lead compound that could be used in the treatment of human airway disorders.
The agreement is for the development and commercialization of Rhizen's, inhaled dual PI3K-delta gamma inhibitor and its closely related compounds for various indications.
Speaking to CNBC-TV18, Dr Arun Chandavarkar, CEO & Joint MD, Biocon says that the company is also looking to introduce its biosimilars and insulin portfolio in the UAE.