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- Read more about Regeneron and Sanofi to reduce price of their Cardiovascular Medicine
Regeneron Pharmaceuticals, Inc. and Sanofi announced they will lower the net price of Praluent® (alirocumab) Injection in exchange for straightforward, more affordable patient access from Express Scripts. Praluent will become the exclusive PCSK9 inhibitor therapy on the Express Scripts national formulary. The agreement significantly simplifies the documentation necessary to secure insurance coverage and may help reduce out-of-pocket costs for eligible patients. Despite having the broadest U.S. formulary coverage of any PCSK9 inhibitor, many patients have been unable to access Praluent because of the complicated utilization management process required by some insurance companies and high patient out-of-pocket costs.
- Read more about FDA nod for Cipla's Generic Vazculep ® and Phenylephrine Hydrochloride
Cipla Limited, a global pharmaceutical company, announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Phenylephrine Hydrochloride Injection USP, 50 mg/5 mL (10 mg/mL) and 100 mg/10 mL (10 mg/mL) Pharmacy Bulk Package, Phenylephrine Hydrochloride Injection USP, 10 mg/mL Single- Dose Vial and Exemestane Tablets, 25mg from the United States Food and Drug Administration (USFDA).

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- Read more about Government push pain killer Tramadol under narcotics laws
Government of India brings Tramadol, a synthetic opioid pain killer, under the control of the Narcotic Drugs and Psychotropic Substances (NDPS) Act 1985. Tramadol is also known as ISIS Drug. ISIS militants are known to abuse tramadol to suppress pain and boost strength during injury. International anti-narcotics authorities also called it as fighter drug.
- Read more about FDA, FTC take action against companies for misleading kids with e-liquids
U.S. Food and Drug Administration and the Federal Trade Commission (FTC) issued 13 warning letter to manufacturers, distributors, and retailers for selling e-liquids used in e-cigarettes that resemble kid-friendly food products, such as juice boxes, candy or cookies, some of them with cartoon-like imagery.
- Read more about NPPA has fixed/revised ceiling prices/retail prices of 37 formulations under DPCO , 2013
NPPA has fixed/revised ceiling prices/retail prices of 37 formulations under DPCO , 2013. The different formulation are:

Rosuvastatin + Aspirin+ Clopidogrel Capsule (R2 Trio 10), Rosuvastatin + Aspirin + Clopidogrel Capsule (R2 Trio 20), Atorvastatin + Clopidogrel Capsule (Stator CV), Amoxycillin + Clavulnic Suspension, Paclitaxel Injection (Nab-Altaxel 100mg), Escitalopram + Clonazepam Tablet (Szetalo Plus 5), Teneligliptin + Metformin Tablet (Terostil M), Glimepride + Metformin Tablet (Glimison-M2 Forte), Glimepride + Metformin Tablet (Glimison-M1 Forte), Metoprolol + Amlodipine Tablet (MPROL-AM 25/5), Telmisartan + Chlorthalidone Tablet (Telmiride – CH 6.25), Telmisartan + Chlorthalidone Tablet, Ferrous + Folic Acid + Elemental Tablet (Tonofolic – XT), Voglibose + Glimepride + Metformin Tablet (Voglyson GM1), Voglibose + Glimepride + Metformin Tablet (Voglyson GM2), Doxorubicin Injection, Glimiepiride + Metformin Tablet (GLYCOMET GP 3 Forte), Rosuvastation + Aspirin + Clopidogrel capsule, Rosuvastation + Aspirin + Clopidogrel Capsule, Paclitaxel (Protein bound Particles) for Injectable Suspension, Glimepiride + Metformin Tablet (Glimy M 0.5mg), Gliclazide + Metformin Tablet, Doxorubicin Hydrochloride liposomal Injection, Teneligliptin + Metformin Tablet, Rosuvastatin + Aspirin Capsules, Metformin + Glimepiride Tablet, Amoxycillin + Clavulanic Dry Syrup
- Read more about CHMP positive opinion to change in term of marketing approval for Amgen's Prolia
Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Prolia. The marketing authorisation holder for this medicinal product is Amgen Europe B.V.
- Read more about FDA warns about serious immune system reaction with lamotrigine (Lamictal)
The Food and Drug Administration (FDA) has issued warning regarding the use of lamotrigine and the possibility of hemophagocytic lymphohistiocytosis (HLH), a rare but serious immune system reaction. The FDA is requiring that a new warning be added to the prescribing information for all lamotrigine products to alert of this possible side effect.
- Read more about The combination of Anti-HIV drug does not raise preterm birth problems: study says
A drug combination aimed at preventing transmission of HIV from a pregnant woman to her fetus likely does not increase the risk for preterm birth and early infant death, according to a re-analysis of two studies funded by the National Institutes of Health. The research appears in the New England Journal of Medicine.
- Read more about FDA’s new efforts to enhance and modernize approach to medical device safety and innovation
Advances in material science, digital technology and advanced manufacturing are contributing to an unparalleled period of invention in medical devices. Last year, the FDA approved first artificial pancreas and the first blood test to evaluate traumatic brain injury. The FDA plays a crucial role in the efficient development of these technologies.
- Read more about FDA authorizes first test to identify the emerging pathogen Candida auris
U.S. Food and Drug Administration authorized the first test to identify the emerging pathogen Candida auris (C. auris), which can cause serious infections in hospitalized patients.