All Clarivate websites use cookies to improve your online experience. They were placed on your computer when you launched this website. You can change your cookie settings through your browser.

More information on our cookie policy.

BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
  • Special reports
    • Aging
    • Biosimilars
    • Artificial intelligence
    • Coronavirus
    • IVDs on the rise
    • Science '22 in Review
    • Top Biopharma Trends of 2022
    • Top Med-tech Trends of 2022
    • Premium reports
      • BioWorld Financings Reports
      • Disease Incidence & Prevalence Summaries

BioWorld. Link to homepage.

  • sign in
  • Sign Out
  • My Account
Subscribe
BioWorld - Thursday, March 23, 2023
Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

Regulatory front for Aug. 12, 2020

Aug. 12, 2020
No Comments
The latest global regulatory news, changes and updates affecting biopharma.
Read More

Regulatory actions for Aug. 12, 2020

Aug. 12, 2020
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akari, Arca, Ascendis, Eli Lilly, Epirium, Eyegate, Indian, Innovent, Kahr, Kineta, Pliant, Redhill, Regeneron, Seattle Genetics, Theranexus.
Read More

NS Pharma’s Viltepso cleared to take on troubled DMD drug Vyondys

Aug. 12, 2020
By Jennifer Boggs
No Comments
The FDA granted accelerated approval to Viltepso (viltolarsen) to treat Duchenne muscular dystrophy patients (DMD) who have a confirmed mutation of the DMD gene amenable to exon 53 skipping, pitting it against Sarepta Therapeutics Inc.’s Vyondys (golodirsen), which was given accelerated approval last year in a controversial decision by the FDA following an agency complete response letter (CRL) highlighting safety concerns.
Read More
Amyloid plaque on nerve cell

Yes we aducanumab? Biogen/Eisai AD bid gains traction, outlook still divided

Aug. 11, 2020
By Randy Osborne
No Comments
News from Biogen Inc. and partner Eisai Co. Ltd. that U.S. regulators accepted the BLA related to aducanumab for Alzheimer’s disease (AD) – and assigned it priority review, no less – set Wall Street abuzz.
Read More

Ascletis’ all-oral HCV treatment approved for marketing in China

Aug. 11, 2020
By Bryan Wong
No Comments
HONG KONG – The recent approval of all-oral hepatitis C virus (HCV) drug RDV/DNV, a combination of Asclevir (ravidasvir) and Ganovo (danoprevir), helped boost shares of Ascletis Pharma Inc. (HK:1672), which ended July with a 10% jump to HK$3.36 (US43 cents), as the Hangzhou, China-based company continues to push its pipeline of treatments forward and improve its outlook.
Read More
Pakistan flag-map

Import bans hit Pakistan’s pharma industry

Aug. 11, 2020
By Khawar Khan
No Comments
KARACHI, Pakistan – Geopolitics and a fraught relationship with its neighbors are hurting Pakistan’s pharmaceutical industry and the ability of people to access active pharmaceutical ingredients (APIs) and modern drugs.
Read More

Fennec's Pedmark lands CRL over manufacturing issues

Aug. 11, 2020
By Michael Fitzhugh
No Comments
Manufacturing deficiencies triggered an FDA complete response letter for Fennec Pharmaceuticals Inc.'s Pedmark, a medicine intended to prevent ototoxicity associated with cisplatin use in children with certain solid tumors.
Read More
COVID-19 vaccine vials

From Russia with flub? Safety jitters ripple after quick COVID-19 vaccine approval

Aug. 11, 2020
By Randy Osborne
No Comments
Reports out of Russia that the country approved a COVID-19 vaccine came with more questions than answers, as some in the rest of the world fretted over the apparently paltry degree of testing. Though the product has not completed phase III trials – human research thus far has involved only two groups of volunteers of 38 people each – Russia President Vladimir Putin is said to have declared Gam-COVID-Vac adequately studied.
Read More
Financial chart, downward arrow

Mesoblast sees stock tumble 31% ahead of FDA adcom meeting

Aug. 11, 2020
By Tamra Sami
No Comments
PERTH, Australia – Australian regenerative medicine company Mesoblast Ltd. saw its stock tumble more than 30% following the release of briefing documents from the FDA ahead of an Aug. 13 advisory committee meeting to review the company’s BLA for Ryoncil (remestemcel-L) for steroid-refractory acute graft versus host disease (SR-aGVHD) in children.
Read More
U.S. Capitol building

Domestic Rx, device supply chain a tall order

Aug. 11, 2020
By Mari Serebrov
No Comments
“There’s a difference in knowing something and realizing something. We’ve known for quite a while now that we’re too dependent on other countries for our medical supplies. But during this pandemic, I think we’ve realized it,” U.S. Rep. Buddy Carter (R-Ga.) said at a recent congressional hearing on the progress being made in developing COVID-19 vaccines.
Read More
Previous 1 2 … 433 434 435 436 437 438 439 440 441 … 947 948 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for March 22, 2023.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for March 22, 2022.
  • Woman with headache

    Nasal spray Zavzpret cleared, Pfizer showing ‘growth on every measure’ in migraine

    BioWorld
    Pricing won’t be known until later for Pfizer Inc.’s Zavzpret (zavegepant), which became the first and only calcitonin gene-related peptide receptor antagonist...
  • Kirill Pevzner and Eran Seger - Protai

    AI drug discovery startup Protai raises $12M in seed funding

    BioWorld
    Artificial intelligence (AI)-powered drug discovery startup Protai Bio Ltd. raised $12 million in additional seed funding, bringing the total amount to $20...
  • Targets with arrows

    Flagship puts $50M toward targeted tissue-homing tech startup

    BioWorld
    In an ideal world, when a patient takes a medicine, it acts only at the specific site of disease in the human body whilst sparing healthy tissues. But it almost...
black cortellis ad

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription.

Subscribe
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
Follow Us

Copyright ©2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing