Biocon Ltd today announced that the U.S. Food and Drug Administration (USFDA) has issued a Complete Response Letter (CRL) for the company’s Biologics License Application (BLA) seeking approval for its proposed biosimilar bevacizumab. Bevacizumab is an anti-cancer drug used to treat various types of cancers. Biocon has developed a biosimilar version of bevacizumab under the […]
Animal healthcare company Hester Biosciences’ quarterly revenues and profits declined on a year-on-year basis due to a sharp fall in its revenue from animal healthcare. Hester’s total standalone revenues for Q3 FY24 decreased by 7% to Rs 655.05 crore compared to Rs 707.73 crore in the year-ago period, mainly due to an 18% decline in […]
Indian pharmaceutical company Panacea Biotec Ltd announced today that it has received notice of an arbitration proceeding initiated by Canadian firm Apotex Inc. The dispute relates to a 2014 collaboration agreement between the two companies for the development and supply of a pharmaceutical product aimed at the US market. Apotex has claimed damages of $118.14 […]
Sun Pharmaceutical Industries Limited, India’s largest pharmaceutical company, has announced equity investments in two healthcare startups – Ezerx Health Tech and Agatsa Software. The pharmaceuticals company said these companies possess innovative technologies in areas of pharma and healthcare. As per a regulatory filing, Sun Pharma has entered into an agreement to acquire 37.76% stake in […]
The growth in US generic sales of leading Indian pharmaceutical companies moderated in the three months ended August 2023. Total sales of generic drugs in the US declined 0.5% compared to the three months ended July and 1.9% compared to the three months ended May. Moreover, the annualized number of Abbreviated New Drug Applications (ANDA) […]
A bidding war is reportedly heating up for Biogen’s biosimilars portfolio, with three major pharmaceutical companies reportedly offering around $1 billion for the business unit – Samsung Bioepis, India’s Dr. Reddy’s Laboratories, and Intas Pharmaceuticals. Of the three, Samsung and Intas may be placed to gain the maximum from the acquisition. Biogen’s biosimilars division focuses […]
The Indian pharmaceutical market is expected to show a recovery in the second half of the financial year, according to analysts tracking this sector. Pharma sales grew by 10.1% in the 12 months ending August 2023 compared to the same period last year. This growth was driven by a combination of price increases, new product […]
A new report by Kotak Institutional Equities suggests that investors may be underestimating the threat posed by generic drugs to the ‘branded generics’ business of leading Indian pharmaceutical companies. The report highlights that current implied valuations of around 30-40x FY2025 EPS for most major pharma firms assume a relatively benign 10-11% growth in the Indian […]
Equity research firm Systematix Institutional Equities has initiated coverage on pharmaceutical major Pfizer Ltd with a “Buy” rating and set a target price of Rs 4,954, indicating an upside potential of around 30% from current levels. The broking house said the recent slowdown in Pfizer Inc’s Indian subsidiary was due to temporary factors and its […]
Zydus Cadila said it received tentative approval from the USFDA to market Pimavanserin tablets — a generic form of Acadia Pharmaceuticals’ Nuplazid — in the US. Tentative approval refers to approval given ahead of patent expiry. The company will be able to start selling the drug only when the patent protection expires. The compound, as […]
Strides Pharma Science Ltd said its mega vaccine plant in Bangalore is ready and has started commercially producing Russian COVID vaccine Sputnik Light. “As previously committed, the company is on track to commercialize this vaccine for Global markets in Q4FY22,” it added. Strides Pharma unit Stelis was the third pharma manufacturer in India to sign […]
In one of the most eagerly awaited studies in recent months, South African scientists have established that Pfizer’s mRNA vaccine alone will not be of much use in preventing or neutralizing the new variant of COVID-19 virus, known as Omicron. The results also suggest that other vaccines — which too target only the spike protein […]
Biocon, one of most prominent Indian pharmaceutical companies focused on developing its own drugs and formulations, kicked off its expansion into the Middle East market with an out-licensing deal with Saudi Arabia-based Tabuk Pharmaceutical Manufacturing Co. Biocon did not list the products that are covered by the licensing deal, but said it would cover “select […]
Morepen Laboratories said it expects its US export business to get a major boost now that the US FDA has given it the go-ahead to export allergy drug Allegra to that market. Fexofinadine, invented by Sanofi Aventis, is the most widely used, second generation antihistamine drug for the treatment of allergy symptoms and hay fever, […]
Medical devices and chemicals manufacturer Morepen Laboratories reported a strong increase in revenue and profitability, as demand for its home diagnostic equipment such as glucose meters shot up in the aftermath of the COVID-19 pandemic. The company’s revenue for the Jul-Sep period jumped by 17% on year to Rs 398 cr, while net profit jumped […]
Cadila Healthcare, also known as Zydus Cadila, said it has started enrolling patients in a trial that can potentially yield the first FDA approved treatment for NASH or non-alcoholic fatty liver disease with inflammation. Fatty liver disease, caused by the deposition of fat in the liver, is divided into alcohol-related and non-alcohol related. Within non-alcoholic […]
Biocon subsidiary Biocon Biologics Limited (BBL) said its insulin substitute Insulin Glargine has been included by Express Scripts — a prominent ‘pharmacy benefits manager’ in the US — in its National Preferred Formulary. Pharmacy benefits manager, as the name implies, is a kind of outsourced service provider that manages pharmacy benefits extended to employees by […]
India-based Lincoln Pharmaceuticals Ltd said it is looking forward to entering the Australian market, after Australia’s medicines and medical devices regulator – Therapeutic Goods Administration {TGA) – approved the company’s primary manufacturing plant in Khatraj, Gujarat. The approval, said the medicine manufacturer, has been granted for all three sections, tablets, capsules and creams & ointments. […]
Biopharmaceuticals manufacturer Biocon Ltd launched cancer medication Everolimus tablets in the US. The formulation, a generic version of Afinitor from Novartis, is a prescription medication that is used to treat certain types of cancers and tumours. The tablet has annual sales of around $675 mln in the US, which makes it among the larger drugs […]
Cadila Healthcare, also known as Zydus Cadila, has taken one more step towards augmenting the production capacity for its DNA-based Covid vaccine known as ZyCoV-D by inking an agreement with Shilpa Medicare. Under the agreement, Shilpa Medicare Ltd will use its biologics manufacturing plant at Dharwad, Karnataka, to manufacture ZyCoV-D. ZyCoV-D is the world’s first […]
