Latest Drug Approvals NewsRSS

03:14 EST 25th February 2018 | BioPortfolio

Global and North America Pharmaceutical Blister Packaging Market Status and Future Forecast 20132023 [Report Updated: 07022018] Prices from USD $2500

SummaryKey Content of Chapters Including and can be customizedPart 1:Market Overview, Development, and Segment by Type, Application RegionPart 2:Global Market by company, Type, Application RegionPart 3:North America Market by company, Type, Application RegionPart 46:Key Regions of North America Market by Type, ApplicationPart 7:Company information, Sales, Cost, Margin etc.Part 8:ConclusionMarke...

Drug That Promises to Kill Flu in a Day Approved in Japan

Japan has approved a drug that its maker says can kill the flu virus in 24 hours, advancing what health experts believe could be a breakthrough in the way the illness is treated. Friday's fast-tracked approval from Japan's health ministry means Shionogi & Co.

Patients Eagerly Awaited a Generic Drug. Then They Saw the Price.

When Teva Pharmaceuticals announced recently that it would begin selling a copycat version of Syprine - an expensive drug invented in the 1960s - the news seemed like a welcome development for people taking old drugs that have skyrocketed in price. Syprine, which treats a rare condition known as Wilson disease, gained notoriety after Valeant Pharmaceuticals International raised the price of the dr...

EU Panel Recommends Olaparib Tablets for Ovarian Cancer, Regardless of BRCA Status

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of olaparib tablets (Lynparza) as a maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. 

Denosumab Approaches European Approval for Myeloma

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of denosumab (Xgeva) for the prevention of skeletal-related events in patients with multiple myeloma.

Novo Nordisk Gets Close to Launching the First Oral GLP-1 Drug for Diabetes

Novo Nordisk has positive Phase III trial results for its oral version of semaglutide, a GLP-1 based treatment for type II diabetes. This could be the first oral GLP-1 treatment on the market, making it easier for patients to take ... This awesome article Novo Nordisk Gets Close to Launching the First Oral GLP-1 Drug for Diabetes appeared first on Be kind and don't copy it without as...

Gomella Discusses Apalutamide Approval and Other Progress in Prostate Cancer

Leonard Gomella, MD, shares his insight on the recent FDA approvals and other ongoing progress in the treatment of patients with prostate cancer.

News and press releases: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2018

Five medicines recommended for approval, including two orphans

MagForce (MF6) - US NanoTherm IDE approval a major milestone

Edison Investment Research - Pharmaceutical & healthcare - MagForce: MagForce has received IDE approval to start its first pivotal clinical trial evaluating NanoTherm focal ablation therapy for prostate cancer in the US. This is a major milestone for the company. Prostate cancer in the US presents a significant market opportunity (representing ~60% of our rNPV) and makes sense strategically as a f...

Canada’s generics industry to cut prices by up to 40%

The pan-Canadian Pharmaceutical Alliance (pCPA) announced on 29 January 2018 that together with participating federal, provincial and territorial public drug plans, and the Canadian Generic Pharmaceutical Association (CGPA), they are launching a new five-year generics initiative. As a part of this, Canada’s generic drugs industry has agreed to reduce prices of generics in exchange for the r...

Apellis touts new data for eye drug hopeful

Further follow-up of AMD patients treated with Apellis' drug appeared to support earlier Phase 2 results.

FDA Drug Safety Communication: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease

The U.S. Food and Drug Administration (FDA) is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. Our recommendation is based on our review of the results of a 10-year follow-up study1 of patients with coronary heart disease from a large clinical tri...

MabSpace Biosciences Announces FDA Approval of IND for MSB2311, a Second Generation PD-L1 Antibody With pH Dependent Antigen Binding and Recycling Property

MabSpace Biosciences announces on February 16th, 2018 FDA cleared Investigational New Drug (IND) for MSB2311, a humanized programmed death protein-ligand 1 (PD-L1) antibody for the treatment of patients with locally advanced/metastatic solid tumors. MabSpace plans to start a first-in-human, open label, multiple center, dose escalation and dose expansion st...

Scientists In Germany Improve Malaria Drug Production

NewsScientists in Germany who developed a new way to make a key malaria drug several years ago said Wednesday they have come up with a technique to make the process even more efficient, which should increase global access and reduce the cost.

GW Pharma’s Latest Cannabinoid Drug Pegged Back by a Placebo in Phase II

One of GW Pharma’s cannabinoid drugs for epilepsy has suffered a set back in a Phase IIa trial as a placebo matched its capacity to reduce the frequency of focal seizures. GW Pharma wants to use cannabinoid drugs to treat conditions like autism ... This awesome article GW Pharma’s Latest Cannabinoid Drug Pegged Back by a Placebo in Phase II appeared first on Be kind an...

Biohaven teams up with Catalent on CGRP oral drug delivery

Biohaven is to use Catalent's fast-dissolving technology for rapid delivery of its migraine drug.

Adgero Biopharmaceuticals Granted FDA Orphan Drug Designation of REM-001 Therapy for the Treatment of Basal Cell Carcinoma Nevus Syndrome

PRINCETON, NJ--(Marketwired - February 22, 2018) - Adgero Biopharmaceuticals Holdings, Inc. ("Adgero" or the "Company"), a privately-held biopharmaceutical company leveraging its late stage photodynamic therapy ("PDT") platform for the treatment of serious cutaneous oncology indications, announced today that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation to REM-0...

Novo Nordisk’s Positive Phase III Data for Oral Diabetic Drug Heats Up the Competition

In an already competitive diabetes market, Novo Nordisk may have gained a significant edge with the results of its Phase III trial of GLP-1 drug Ozempic (semaglutide).

STAT Plus: Vertex gets regulator sign-off on accelerated cystic fibrosis drug trial

The speedy trial design means the first of Vertex’s three-drug regimens for cystic fibrosis could have top-line results by the end of this year or early in 2019 — faster…

Clovis Oncology Receives Positive Trend Vote from CHMP in European Regulatory Review for Rucaparib Ovarian Cancer Treatment Indication

The CHMP has communicated a positive trend vote for the rucaparib MAA under review for the treatment of women with advanced BRCA-mutant ovarian cancer and expects to vote on the treatment indication at their scheduled meeting in March 2018 Pending a positive recommendation by CHMP, final approval by the European Commission w...

CHI’s Discovery on Target, Sheraton Boston, Sept. 25-28, 2018

CHI’s Discovery on Target, Sheraton Boston, Sept. 25-28, 2018 Reporter: Aviva Lev-Ari, PhD, RN   ANNOUNCEMENT Leaders in Pharmaceutical Business Intelligence (LPBI) Group is a selected CHI Business Partner for Media Communication for this event as well a provider of REAL TIME PRESS COVERAGE for this cardinal event in the domain of  Drug Discovery and Drug Delivery. Dr. Aviva [̷...

Roche In Strategic Partnership With Emulate For Drug Discovery Platform

NewsThe partnership will use Emulate's lab-ready Human Emulation System comprised of Organ-Chips, instrumentation, and software apps to discover and develop new classes of therapeutic antibodies and drug combinations.

Emulate In Strategic Partnership With Roche For Drug Discovery Platform

NewsEmulate, Inc. announces strategic partnership with leading pharmaceutical company to apply the ‘Human Emulation System’ as a platform for drug discovery.

Mylan Receives Tentative Approval For Combination HIV Treatment

NewsFDA's tentative approval of Mylan's NDA for dolutegravir, emtricitabine, and tenofovir alafenamide tablets was issued under the President's Emergency Plan for AIDS Relief (PEPFAR). The antiretroviral will be immediately available in developing countries.

Ionis Licenses New Antisense Drug For Kidney Disease To AstraZeneca

NewsUnder the deal, Ionis receives a $30 million license fee and may also receive up to $300 million in additional payments. AstraZeneca will be responsible for developing and commercializing the drug to treat a genetically associated form of kidney disease.

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