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, […]
An interesting, observational study in the UK suggests that the overactive immune system associated with allergic diseases such as asthma and hay fever may have a positive side-effect in the form of greater protection from COVID-19 in the initial stages. The 10-month study, involving around 15,000 people, was carried out between May 2020 and February […]
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. […]
Max Healthcare Institute Ltd, one of India’s largest hostpital chains, said it has been allocated around 11.36 acres of land in the heart of Gurgaon city to set up two hospitals. The two plots, allocated by Haryana Shahri Vikas Pradhikaran, measure 6.11 acres and 5.26 acres. Both plots are in well populated areas of Gurgaon, […]
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 […]
Six months after getting a VAI status from the US Food & Drug Administration for its insulin glargine manufacturing facility in Malaysia, Biocon — India’s largest biopharmaceuticals company — said the US FDA issued six observations after pre-approval inspections at its insulin aspart plant in that country. Insulin glargine is a long-acting insulin-substitute, while insulin […]
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 […]
Zydus Cadila said it received approval from the US Food & Drug Administration to sell new generation anti-depressant Vortioxetine in the US market. The drug was first approved around seven years ago, and was developed by Denmark-based pharmaceuticals maker Lundbeck in the late 2000s. Around 2007, Japanese pharmaceuticals maker Takeda agreed to pay an upfront […]
Indian pharmaceuticals manufacturer Lupin Ltd said it received a non-exclusive license to manufacture the anti-TB drug pretomanid from non-profit drug developer, TB Alliance. The company said it plans to sell the drug in 140 countries and territories, including many of the highest TB burden countries around the world. Pretomanid will be administered as part of […]
Zydus Cadila said it received six-month exclusivity for the sale of generic tofacitinib, a drug that has annual sales of over $2 billion in the US. The exclusivity was provided by the US FDA, since Cadila Healthcare was the first to file an abbreviated new drug application or ANDA for the drug. An ANDA is […]
Zydus Cadila has finally said it got Emergency Use Authorization (EUA) from Indian authorities to administer ZyCoV-D — the world’s first DNA-based COVID-19 vaccine — for both adults and teenagers. This is the first time any COVID-19 vaccine has been approved for those below 18 years of age in India. The approval has been given […]
Cadila Healthcare said it has launched a generic blood thinning medication, Enoxaparin Sodium Injection, in the US, where the drug has annual sales of around $513 mn, or around Rs 3,800 cr. With this, the company has become the first Indian firm to launch a generic version of the drug in that market. Enoxaparin Sodium […]
Cadila Healthcare MD Sharvil Patel said the company has started stockpiling the ZyCoV-D COVID vaccine, and is in the process of providing additional data to drug regulators and hopes to get the shot approved in one or two weeks. If approved, ZyCoV-D will become the first vaccine anywhere in the world to use DNA to […]
Pharmaceuticals manufacturer Alkem Laboratories said its bioequivalence center at Taloja in Maharashtra has successfully undergone a US FDA inspection without attracting any adverse remarks. “US FDA had conducted a remote and virtual Bio-Analytical inspection of the Company’s Bioequivalence Center located at Taloja, Maharashtra from 26th July, 2021 to 28th July, 2021. At the end of […]
The Indian unit of French pharmaceuticals maker Sanofi said it decided to sell its nutraceuticals business Universal Nutriscience Private Ltd for Rs 587.0 cr ($80 mln) plus debt-like obligations such as retirals and provisions for sales returns. Universal Nutriscience is a joint venture between Kedaara Capital Fund II LLP and Universal Medicare Private Limited. The […]
Sun Pharma, one of India’s largest pharmaceuticals manufacturers, said it has acquired the exclusive license to sell an acne cream in the US and Canada for an upfront payment of $45 million and potential milestone payments of up to $190 mln. The rights to sell Winlevi branded clascoterone cream were acquired from Italy-based Cassiopea SpA. […]
