Latest Drug Approvals NewsRSS

10:29 EDT 21st June 2018 | BioPortfolio

PhoreMost and o2h discovery collaborate to progress first-in-class drug discovery programs

PhoreMost, the UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets, today announced it has entered into a collaboration with o2h discovery (o2h), an Anglo-Indian medicinal chemistry company that has in-house capability to take drug discovery programmes to the IND filing stage. This press release features multimedia. Vi...

STAT Plus: Number of drug makers lobbying Congress on pricing issues skyrockets

The number of companies that cited “drug pricing” or variations on the phrase in disclosure documents has more than quadrupled in the last five years, according to a new report.

Teligent Announces FDA Approval of Fluocinonide Gel, 0.05%

Teligent (NASDAQ:TLGT) has announced it has received US FDA approval of its new drug application of FLuocinonide Gel, 0.05 percent. As quoted in the press release:  This is Teligent’s sixth approval for 2018, and its twenty-fifth approval from its internally-developed pipeline of topical generic pharmaceutical medicines. Based on recent IQVIA data from April 2018, the … Continued The post...

Glenmark’s generic Malarone gets FDA OK

Looking Way Down Into the Cells

Pharmacokinetics – the study of how drugs are taken up, distributed, metabolized, and cleared – is obviously a key part of drug development. Every drug substance gets handled somewhat differently by the human body, and these differences can completely determine whether you’ve got an effective therapy or not. But the tools we have to get

STAT Plus: Pharmalittle: A campaign downplays concerns over antibiotics given animals; U.K. parents step up fight over Vertex drug

Cystic fibrosis patients in the U.K. are stepping up efforts to resolve a “heartbreaking” row that is denying their families access to the Orkambi drug sold by Vertex Pharmaceuticals

Global Implantable Drug Delivery Devices Market Analysis, Trends, Market Size & Forecasts up to 2024, With an Expected CAGR of 6.22% -

The "Implantable Drug Delivery Devices Market: Global Industry Analysis, Trends, Market Size, and Forecasts up to 2024" report has been added to's offering. The global implantable drug delivery devices market was worth USD 13,499.43 million in 2017 and it is projected to reach USD 20,589.07 million in 2024, expanding ...

Anika shares slump on Phase 3 miss

The regenerative medicine company's osteoarthritis treatment failed to meet its goal, spurring investor worries about approval in the U.S. 

Targeted Drug May Aid Pancreatic Cancer Patients With BRCA Mutation

ArticleUnder normal circumstances, BRCA keeps tumors at bay by repairing damaged DNA. However, a mutation in BRCA causes it to lose its tumor-suppressing abilities, increasing susceptibility to cancer.

Canada Becomes Second Country to End Marijuana Prohibition; Regulated Adult Sales to Begin Later This Year

June 20, 2018 ( Newswire) A bill to legalize and regulate marijuana for adult use in Canada received final approval from lawmakers Tuesday and will now be sent to the governor general for royal assent.

Teligent, Inc. Announces FDA Approval of Fluocinonide Gel, 0.05%

BUENA, N.J., June 20, 2018 (GLOBE NEWSWIRE) -- Teligent, Inc. (NASDAQ:TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced it has received approval of the Company’s abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) of Fluocinonide Gel, 0.05%.  This is Teligent’s sixth approval for 2018, and its twenty-fifth approval from...

Moleculin Receives Approval for Leukemia Clinical Trial

HOUSTON, June 20, 2018 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has received Polish National Office appro...

Array Hope Rises as Potential FDA Approval of Melanoma Treatment Nears

Array is anxiously awaiting the FDA to approve its combination treatment for BRAF-mutant metastatic melanoma.If approved, Chief Executive Officer Ron Squarer believes it will not only be an important milestone for the company, but also for the patients.

Myriad Receives FDA SPMA Approval for BRACAnalysis CDx

Once approved, BRACAnalysis CDx will be used with Pfizer's PARB inhibitor, talazoparib. Talazoparib has a prescription drug user fee act goal date of later this year. The post Myriad Receives FDA SPMA Approval for BRACAnalysis CDx appeared first on Investing News Network.

The ‘New Pharma’: Synthetic biology reimagines drug development

The post The ‘New Pharma’: Synthetic biology reimagines drug development appeared first on SynBioBeta.

GE looks to speed drug discovery with new high capacity system

GE has introduced a new high capacity system designed to improve productivity in the increasingly complex drug discovery process.

STAT Plus: Key lawmaker calls for more scrutiny of hospitals using drug discount program — but no broader changes

Sen. Lamar Alexander stopped far short of sweeping changes to the program that the drug industry wants.

Arch Biopartners to Seek Regulatory Guidance From the U.S FDA for AB569

ARch Biopartners (TSXV:ARCH) has announced it will seek regulatory guidance from the US Food and Drug Administration in a pre investigational new drug application meeting for AB569, its drug candidate for treating antibiotic resistant bacterial infections in the lungs, wounds and urinary tract. As quoted in the press release: Arch began sponsoring an investigator initiated … Continued The po...

Back to the future? The resurgence of combination drug products

Drugmakers can greatly profit from developing a combination drug, but must address manufacturing and regulatory challenges in the early development stage, says Pharmatech Associates.

FDA advisory committee prep: ‘Work hard on Q&A – that’s where you’ll win it,’ says consultant

Providing a coherent and persuasive risk assessment and a âwell-messaged outline of key communication pointsâ are key to winning US FDA Advisory Committee approval, says industry consultant.

Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products

Statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs in FDA’s Center for Drug Evaluation and Research, on the agency’s response to ongoing drug shortages for critical products

Changing the finish line: Syneos talks bringing payer, patient voice into drug development

The drug development âfinish lineâ is not regulatory approval, says Syenos Health chief scientific officer Judith Ng-Cashin, MD, who discusses bringing the payer and patient voice into the process.

Blinatumomab Granted Full EU Approval for B-cell Precursor ALL

The European Commission has granted blinatumomab full marketing authorization for the treatment of adult patients with Philadelphia chromosome-negative relapsed/refractory B-cell precursor acute lymphoblastic leukemia, according to Amgen, the developer of the anti-CD19 immunotherapy.  

PDA-Funded Study on Post-Approval Changes Published by The Economist Intelligence Unit

Intelligence report analyzes link between post-approval change regulations and drug shortages BETHESDA, Md. (PRWEB) June 19, 2018 PDA today announced the availability of "Medicine and vaccine shortages: What is the role of global regulatory complexity for post approval changes?", a report by The Economist Intelligence Unit. PDA commissioned the report with funds from the Parenteral Drug...

Novus Therapeutics Receives FDA Guidance at Type C Meeting for OP-02 in the Treatment and Prevention of Otitis Media

Novus Therapeutics, Inc. (NASDAQ: NVUS), a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat (ENT), announced receipt of final meeting minutes from the U.S. Food and Drug Administration (FDA) following a Type C meeting held at the Company’s request to discuss its OP-02 development pro...

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