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Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists.
” Shinichi Tamura , Chairman, President and CEO of Sosei Heptares, commented: “We are delighted to enter this collaboration and license agreement with Biohaven for our portfolio of novel CGRP receptor antagonists.
Karst — While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R.
NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand the approval of COMIRNATY® (COVID-19 Vaccine, mRNA) to include individuals ages 12 through 15 years. Pfizer Inc.
In the case of urgent or immediate public interest, process validation may be conducted concurrently with manufacturing the commercial smallmolecule or biologic product to expedite product availability for patients. It ensures that a production process consistently yields products of predetermined quality and safety.
Food and Drug Administration (FDA) are starting to pick up. People living with LN are in need of an advanced therapy that quickly drives the disease into remission and mediates kidney damage,” said Peter Greenleaf, president and chief executive officer of Aurinia, in July 2020 when the FDA accepted the NDA to review. “We Here’s a look.
Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022. “An
In the absence of a clinical trial result or FDA label to point to, how does one create the case and target product profile (TPP) around a new target? and whether a molecule’s pharmacology can help to mitigate safety risk. Finally, as part of a broader pathway analysis, consider potential implications for selectivity.
FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms AgencyIQ analyzed CDER’s novel drug approvals in Fiscal Year 2023, identifying a recovery in approval numbers as the agency resumes a new normal following the pandemic. The FDA also refers to novel products as “New Molecular Entities,” or NMEs.
Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. SLV213 is a novel, orally available, smallmolecule antiviral drug candidate that inhibits human host cell cysteine proteases to block viral entry.
As the CEO of iOnctura, an innovative oncology biopharmaceutical company she co-founded in 2017, Catherine has played a key role in advancing the development of highly targeted smallmolecules aimed at revolutionising cancer treatment. I also felt that the so-called glass ceiling had disappeared – I felt equal and really enjoyed that.
2 On December 6th, 2023, Iptacopan under the brand name Fabhalta was approved by the FDA for the treatment of adults with PNH. 1] Iptacopan was approved by the US Food and Drug Administration (FDA) for the treatment of adults with paroxysmal nocturnal hemoglobinuria in December 2023. [2] Food and Drug Administration (FDA).
link] 01 Aug 2022 Cortexyme is now called Quince Therapeutics You need to be a logged in or subscribed to view this content This smallmolecule is an orally available protease inhibitor targeting the lysine proteases of the periodontal pathogen Porphyromonas gingivalis. This compound is expected to require only once-daily dosing.
Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a smallmolecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. (OTCQB: QBIO), announced today that the U.S. billion by 2027.
” “The emergence of the PROTAC technology represents another breakthrough in the identification of smallmolecule drugs. Small-molecule inhibitors of the MDM2-p53 protein-protein interaction (MDM2 inhibitors) in clinical trials for cancer treatment. ” References:
Zhao, Y.; Aguilar, A.; Bernard, D.;
This drug, approved by the FDA in 2015, targets a protein that regulates cholesterol levels in the blood, offering a novel therapeutic approach for patients who do not respond adequately to statins. This highlighted the importance of defining patent scope and licensing terms in such collaborations.
On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees. FDA-2024-N-0007. FDA-2023-N-2850. 89 FR 61474.
In late October, SetPoint Medical received Breakthrough Device Designation from the FDA for the use of its novel bioelectronic device by patients with rheumatoid arthritis (RA) who have incomplete response to, or are intolerant to multiple biologic drugs. SmallMolecule Inhibitors. The FDA has set an action date of July 7, 2021.
Food and Drug Administration (FDA) for Onivyde (irinotecan liposome injection) for study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen. The drug is a small-molecule inhibitor of the S. Paris-based Ipsen secured Fast Track designation from the U.S.
Food and Drug Administration (FDA) earlier this year as an expansion to the existing EUA for the primary series. The booster schedule is based on the labeling information of the vaccine used for the primary series COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing smallmolecules and biologics to treat and prevent human disease and alleviate suffering. The CNS portfolio includes both smallmolecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.
Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals. Comparing the economic terms of biotechnology licenses from academic institutions with those between commercial firms. Academic licenses had lower royalty rates, deal sizes, and pre-commercial payments compared to corporate licenses.
FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing smallmolecules and biologics to treat and prevent human disease and alleviate suffering. The CNS portfolio includes both smallmolecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.
Auxora is a potent and selective smallmolecule CRAC channel inhibitor that prevents CRAC channel overactivation. The FDA placed a partial clinical hold on the trials, requesting Regeneron modify protocols to decrease the occurrence of cytokine release syndrome in patients. It expects to initiate the trial in 2021.
Ilumetri ® sales grew +125% year-on-year and Seysara ® showed Net Sales performance improvement quarter-on-quarter following clinically relevant FDA label improvement.
10% of its Net Sales in R&D and also invests significantly in business development and in-licensing. .
Growth drivers show steady increases.
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It had been paused for more than a month while the FDA evaluated a serious illness in a UK patient. Both those serotypes are associated with invasive pneumococcal disease globally and are not otherwise in currently licensed conjugate vaccines for use in adults. AstraZeneca reported the U.S. The two trials are PNEU-PATH and PNEU-DAY.
ZTlido ® was approved by the FDA on February 28, 2018. for the treatment of post-herpetic neuralgia. RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica.
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TransCon hGH (lonapegsomatropin) : Lonapegsomatropin is an investigational long-acting prodrug of somatropin (human growth hormone or hGH) currently under review for use in pediatric growth hormone deficiency (GHD) by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA):
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Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and smallmolecules.
Food and Drug Administration (FDA) has granted Fast Track designation to lebrikizumab for moderate-to-severe AD in adult and adolescent patients (aged 12 to less than 18 years of age and weighing at least 40 kg). .’s 1-4 The U.S. ’s Chief Scientific Officer. About Atopic Dermatitis. Source link: [link] nvestor.lilly.com/.
So what about all of the “biotic” terms that pop up in the news, on products labels and even in FDA warning letters? In fact, the FDA has even developed a guidance document for “early clinical trials with live biotherapeutic products [LBPs].” According to the FDA, a recombinant LBP is distinctive from a standard LBP.
Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.
After discussion with the FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases.
where he led the launch of the first FDA-cleared aspiration system for neurovascular mechanical thrombectomy. Prior to that, Taveras was vice president of SmallMolecule Drug Discovery and CMC Development at Biogen Idec, and Alantos Pharmaceuticals, which was acquired by Amgen in 2007. Mogrify – U.K.-based
Food and Drug Administration (FDA) approved the update of the Imbruvica Prescribing Information to include efficacy and safety data for the combination of Imbruvica with rituximab for the treatment of Waldenström’s macroglobulinemia (WM). and by AbbVie outside of the U.S. AbbVie announced that the U.S.
Ocuphire held its end of phase 2 (EOP2) meeting with the FDA in May 2020 to discuss the regulatory pathway for Nyxol in multiple chronic and acute refractive indications. Ocuphire’s pipeline currently includes two small-molecule product candidates targeting front and back of the eye indications. Cantor Fitzgerald & Co.
Food and Drug Administration (FDA), based on preliminary data from Phase 1/2 studies that are currently ongoing in the U.S. The BNT162 program is based on BioNTech’s proprietary mRNA technology and supported by Pfizer’s global vaccine development and manufacturing capabilities. and Germany as well as animal immunogenicity studies.
Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. HLE BiTE ® molecules AMG 199 and AMG 910, targeting mucin 17 (MUC17) and claudin 18.2
Submission of an amended protocol to the FDA for the Phase 3 pivotal trial to expand recruitment to approximately 44,000 participants that allows for the enrollment of new populations. Limited blinded tolerability data from the ongoing Phase 3 trial, confirming the mostly mild to moderate tolerability profile as was observed in Phase 1.
At the end of March, the FDA approved Sarclisa ® in combination with carfilzomib and dexamethasone for patients with relapsed multiple myeloma. FDA-approved quadrivalent meningococcal vaccine indicated for all patients above 2 years of age, was launched in the U.S. The target action date for the FDA decision is October 21, 2021.
The FDA has broadened the Emergency Use Authorization (EUA) for baricitinib to allow for treatment with or without remdesivir. The delay is related to the FDA’s ongoing assessment of JAK inhibitors. Retevmo was approved by the FDA and launched in the U.S. Key Events Over the Last Three Months Regulatory. revenue of $22.5
under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process. “We The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S.
Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.
In addition to today’s submission to the FDA, the companies have already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan and the U.K., and plan to submit applications immediately to other regulatory agencies around the world.
by the middle to end of December 2020.
FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S.
Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021.
Friday, December 11, 2020.
immediately.
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