FDA grants speedy review to Dupixent rare skin disease
Sanofi and Regeneron should hear from the FDA in the autumn whether it will approve their blockbuster immunology drug Dupixent as a therapy for rare […]
Sanofi and Regeneron should hear from the FDA in the autumn whether it will approve their blockbuster immunology drug Dupixent as a therapy for rare […]
Sanofi and Regeneron have added another string to the bow of their immunology blockbuster Dupixent with an FDA approval in eosinophilic oesophagitis (EoE), which could […]
Regeneron has agreed an all-cash deal to acquire CheckMate Pharmaceuticals, adding immune activator vidutolimod to its cancer immunotherapy pipeline and ending a barren spell for […]
AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic rhinosinusitis in people with nasal […]
Sanofi and Regeneron have reported disappointing results in a trial of Dupixent in people with chronic spontaneous urticaria (CSU) who don’t respond to the only […]
Belgian biotech Oxurion has revealed new data from a phase 2 trial of its plasma kallikrein inhibitor THR-149, in development for people with diabetic macular […]
Pfizer has called time on its alliance with Ionis for cholesterol-lowering therapy vupanorsen, after a review of phase 2b data raised some questions about the […]
The FDA has approved Roche’s much-anticipated faricimab for two major causes of blindness, setting up a market clash with Bayer and Regeneron’s market leading drug […]
The FDA has limited the use of COVID-19 antibody therapies developed by Eli Lilly and Regeneron, on the back of data suggesting they have are […]
After regulatory hold-ups in the US and Europe, Ipsen has claimed a confidence-boosting approval in Canada for palovarotene, a rare disease therapy acquired via its […]
Regeneron has enlisted the aid of Ultragenyx to add momentum to the rollout of its recently-approved Evkeeza outside the US, which was approved for an […]
Sanofi and Regeneron have another challenger to their big-selling drug Dupixent for atopic dermatitis, now that the FDA has approved Leo Pharma’s rival antibody tralokinumab. […]
At its second attempt, Novartis has won FDA approval for its cholesterol lowering drug inclisiran, which can reduce levels with just two injections a year. […]
Ionis has reported phase 2b trial data for its Pfizer-partnered antisense drug vupanorsen for cholesterol lowering that showed it met its main efficacy targets, but […]
Norwegian biotech Vaccibody has changed its name to Nykode Therapeutics, and celebrated its new identity with a sizeable deal with Regeneron to develop vaccines for […]
Injectable antibodies targeting PCSK9 have failed to take off as expected in the cholesterol-lowering market, but Merck & Co hopes to do much better with […]
Eisai Presents Results of Lecanemab in P-IIb Study 201 Study for the Treatment of Alzheimer’s Disease at CTAD 2021 Published: Nov 12, 2021 | Tags: […]
The EMA’s human medicines committee has recommended approval of Roche’s Ronapreve and Celltrion’s Regkirona for use in COVID-19, the first antibody-based therapies for coronavirus to […]
Shots: The P-III trial evaluates REGEN-COV (1200mg, SC) vs PBO in a ratio (1:1) in patients who lived in the same household with COVID-19 patients […]
A single dose of the COVID-19 monoclonal antibody therapy developing Regeneron reduced the risk of contracting the virus by around 82% for up to eight […]
Shots: The second P-III trial evaluates the efficacy and safety of Dupixent (300mg weekly) vs PBO in 240 patients aged ≥12yrs. with EoE for 24wks. […]
Roche’s Genentech unit has won FDA approval for Susvimo, an implant for eyesight-robbing disease wet age-related macular degeneration (AMD) that gives patients an alternative to […]
LEO Reports 16-week Results of Tralokinumab in P-III ECZTRA 6 Trial for the Treatment of Moderate-to-Severe Atopic Dermatitis Published: 22 Oct, 2021 | Tags: LEO, […]
Sanofi and Regeneron’s Dupixent has become the first biologic drug to show activity in prurigo nodularis (PN), raising the hope of a new treatment option […]
Shots: The P-III LIBERTY ASTHMA VOYAGE Trial evaluates Dupixent (100/200mg, q2w) + SoC in 408 children aged 6-11yrs. with uncontrolled mod. to sev. asthma The […]
18 months after saying “no” to regular NHS funding for Sanofi and Regeneron’s Dupixent (dupilumab) for severe asthma in initial guidance, NICE has now backed […]
Bristol Myers Squibb’s Zeposia (ozanimod) Receives CHMP’s Positive Opinion for Adult Patients with Moderately to Severely Active Ulcerative Colitis Published: 15 Oct, 2021 | Tags: […]
Shots: The US FDA has accepted for priority review a BLA for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis […]
BMS Reports EMA’s Validation of MAA for Relatlimab and Nivolumab as 1L Treatment for Unresectable or Metastatic Melanoma Published: Oct 1, 2021 | Tags: BMS, […]
Shots: The P-III trial evaluates the efficacy and safety of REGEN-COV (casirivimab and imdevimab, 1200/2400mg) vs PBO in a non-hospitalized patient with COVID-19 The trial […]
In an interview with PharmaShots, Dr. Ahmet Sezer, (Professor in the Department of Medical Oncology at Başkent University), Karl Lewis (Professor in the Division of […]
Everest’s SPR206 Receives the NMPA’s IND Approval for the Treatment of MDR Gram-Negative Bacterial Infections Published: Sept 24, 2021 | Tags: Everest, SPR206, NMPA, IND, […]
There’s no shortage of cancer immunotherapies trying to knock Merck & Co’s Keytruda off the top of the tree in previously-untreated non-small cell lung cancer […]
Any lingering hope that Pfizer’s may finally get a regulatory approval for its nerve growth factor (NGF) inhibitor tanezumab looks to have been dashed after […]
Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, […]
Forte’s FB-401 Fails to Meet Primary Endpoints in P-II Clinical Trial For the Treatment of Atopic Dermatitis Published: Sept 3, 2021 | Tags: Forte, FB-401, […]
Shots: The P-II/III LIBERTY AD PRESCHOOL (part B) involves assessing the efficacy & safety of Dupixent (200/300mg) + low-potency TCS vs TCS alone in 162 […]
AstraZeneca’s AZD7442 has shown that it can prevent COVID-19 infection when given to healthy patients – the first time this has been demonstrated by a […]
There is plenty of evidence that Novartis’ ophthalmology drug Beovu can match its rivals when it comes to efficacy, with less frequent dosing, but the […]
There is plenty of evidence that Novartis’ ophthalmology drug Beovu can match its rivals when it comes to efficacy, with less frequent dosing, but the […]
Eli Lilly had a lot riding on its two phase 3 trials of IL-13 inhibitor lebrikizumab in atopic dermatitis (AD) – and it now looks […]
Medtronic to Acquire Intersect ENT for ~$1.1B Published: Aug 6, 2021 | Tags: Medtronic, Intersect ENT, ~$1.1B Kite Signs a License Agreement with Appia to […]
Sanofi and Regeneron’s latecomer checkpoint inhibitor Libtayo has largely been protected from heavyweight competition in its first niche markets, but now looks set to for […]
Roche Publishes the Results of Evrysdi (risdiplam) in FIREFISH Study to Treat of Type 1 SMA at NEJM Published: July 30, 2021 | Tags: Roche, […]
The FDA has started a priority review of Roche’s bispecific antibody faricimab for two major causes of blindness, preparing for a market showdown with Bayer […]
Shots: The study A of P-III LIBERTY CUPID trial evaluates Dupixent vs SoC in 138 patients aged ≥6 yrs. with CSU who remained symptomatic despite […]
AstraZeneca has formed a partnership with Regeneron to investigate the potential of treating obesity using drugs directed at GPR75, a protective gene identified by scientists […]
Shots: The companies collaborated to research, develop & commercialize small molecules directed against the GPR75 target with the potential to treat obesity and related co-morbidities […]
Shots: The approval is based on the results from a P-III trial evaluating Ronapreve (casirivimab and imdevimab) in high-risk non-hospitalized patients with COVID-19 The results […]
Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem Published: June 18, 2021 | Tags: Lineage, Option Agreement, […]
Shots: The P-III RECOVERY trial evaluating REGEN-COV (8,000 mg) vs usual care alone in seronegative patients with COVID-19 demonstrates 20% reduction in risk of death […]
People who cannot generate an effective immune response against COVID-19 can be protected with an infusion of Regeneron’s antibody therapy REGN-COV, according to new data […]
Amgen has made a play in a hot area of immunology R&D, paying $400 million upfront to claim rights to an OX40-targeting drug from Kyowa […]
Prospects for Novartis’ ophthalmology drug Beovu have taken another dive after the drugmaker reported toxicity issues in a new phase 3 trial in wet age-related […]
Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug […]
Shots: The CHMP recommended the approval of Libtayo as a 1L treatment for adults with NSCLC expressing PD-L1 in ≥50% of tumor cells with no […]
BeiGene Reports Results of Tislelizumab + CT in P-III RATIONALE 309 Study as 1L Treatment for Recurrent or Metastatic Nasopharyngeal Cancer Published: May 21, 2021 […]
Shots: The P-III VOYAGE trial involves assessing Dupixent (100/200mg, q2w, based on weight) + SOC asthma therapy in 408 children aged 6-11yrs. with uncontrolled mod. […]
AzurRx BioPharma Reports Positive Interim P-II Data of MS1819 + PERT for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency Published: May 14, 2021 | […]
Shots: The P-III trial involves assessing libtayo (300mg, IV, q3w) as monothx. vs CT in patients with recurrent or metastatic cervical cancer that has progressed […]
A disparity in UK access to a medicine for Duchenne muscular dystrophy (DMD) has been addressed, after Scotland gave a green light to use of […]
Regeneron is to ask the FDA for clearance to use its antibody cocktail as a preventive treatment for COVID-19. The therapy is already authorised by […]
Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12 Published: Mar 26, 2021 | Tags: Pfizer and BioNTech, Initiate, COVID-19 Vaccine Trial, Children, […]
Regeneron has posted findings from a large trial its COVID-19 antibody cocktail showing it reduced risk of hospitalisation or death by 70%. The US pharma […]
Shots: The P-III trial involves assessing REGEN-COV (casirivimab & imdevimab, 1200/2400mg, IV) vs PBO in non-hospitalized patients with COVID-19 The trial met its 1EPs i.e. […]
The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. […]
The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. […]
Sanofi and Regeneron’s checkpoint inhibitor Libtayo has become the first immunotherapy to improve survival when used as a second-line therapy in cervical cancer, setting up […]
Shots: The P-III trial involves assessing Libtayo (300mg, IV, q3w) as monothx. vs CT in patients with recurrent or metastatic cervical cancer that has progressed […]
Last year, Belgium’s ExeVir Bio raised 23 million euros ($27 million) to finance development of llama antibodies – and now it is ready to begin […]
The EMA’s human medicines committee has said two Eli Lilly antibodies are effective in people with COVID-19 who are at risk of developing severe disease, […]
Eli Lilly and Incyte Report Results of Olumiant (baricitinib) in P-III BRAVE-AA2 Study for Severe Alopecia Areata Published: Mar 5, 2021 | Tags: Eli Lilly […]
Eli Lilly’s JAK inhibitor Olumiant has become the first drug in the JAK inhibitor class to be recommended for NHS use in England and Wales […]
Shots: The EMA’s CHMP has recommended the use of casirivimab + imdevimab in patients with confirmed COVID-19 who do not require oxygen supplementation and who […]
Regeneron Reports IDMC Clearance of Efficacy for REGEN-COV (Casirivimab + Imdevimab) in P-III COVID-19 Outpatient Outcomes Trial Published: Feb 26, 2021 | Tags: Regeneron, Reports, […]
Shots: Regeneron reported changes to the P-III study assessing REGEN-COV in non-hospitalized patients with COVID-19, following recommendations from the IDMC The IDMC found clear clinical […]
Shots: The approval is based on the P-III EMPOWER-Lung 1 trial assessing Libtayo (350mg, q3w) monothx. vs platinum doublet CT in 710 patients for the […]
Visby’s POC COVID-19 Test Receives the US FDA’s EUA for Use in CLIA Waived Settings Published: Feb 12, 2020 | Tags: Visby, POC, COVID-19, Test, Receives, […]
Shots: The approval is based on P-III ELIPSE trial that involves assessing Evkeeza (15 mg/kg, IV, q4w) + vs PBO in 65 patients aged ≥12yrs. […]
The FDA has granted an emergency licence for Eli Lilly’s COVID-19 antibody combination therapy, to reduce chances of high-risk patients progressing from mild to moderate […]
Shots: The FDA approval is based on P-II trial involves assessing Libtayo (350mg, q3w) in patients with locally advanced BCC & metastatic BCC (nodal or […]
NICE has recommended regular NHS funding for Novartis’ long-acting eye drug Beovu (brolucizumab) in England and Wales – but a patient group warned that access […]
Roche Collaborate with Cambridge Quantum Computing to Develop Quantum Algorithm for Drug Discovery and Development Published: Jan 29, 2020 | Tags: Roche, Collaborate, Cambridge Quantum Computing, […]
Shots: REGEN-COV neutralizes the SARS-CoV-2 B.1.1.7 variants, identified in the UK & SA. The data was included in a bioRxiv paper and submitted for peer-reviewed […]
Regeneron is considering an emergency filing for its antibody cocktail REGEN-COV to protect people against COVID-19 after early trial results showed it conferred 100% protection […]
Shots: The ongoing P-III trial involves assessing REGEN-COV (casirivimab & imdevimab) in 2000+ participants used as a passive vaccine to prevent COVID-19. An exploratory analysis, […]
The fourth quarter of 2020 contains multiple initiations of clinical trials, big approvals, and numerous deals. COVID-19 related news remains at the peak in this […]
Shots: Roche confirms that the US govt. will purchase additional supply of Regeneron’s Ab cocktail for use in non-hospitalized COVID-19 patients as part of Operation […]
Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, […]
Shots: The company reported encouraging initial data from an ongoing P-I/II/III trial of its casirivimab + imdevimab (8,000/2,400mg) in hospitalized COVID-19 patients requiring low-flow oxygen. […]
UK-based EUSA Pharma has begun a late-stage trial of its antibody siltuximab in COVID-19, hoping that the IL-6 inhibitor will succeed where class rivals from […]
Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, […]
Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, […]
Shots: Penn allied with Regeneron to investigate Ab cocktail (casirivimab & imdevimab) to prevent COVID-19 infection when delivering intranasally via AAV vectors The collaboration b/w […]
Merck Collaborates with Siemens for the Digitalization of Production Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign CoSara Receives CDSCO’s Approval […]
Regeneron’s antibody cocktail is the latest COVID-19 drug to receive Emergency Use Authorization in the US, becoming the first therapy of this kind to become […]
Shots: The US FDA has issued a EUA for casirivimab (1,200mg) + imdevimab (1,200mg) administered together for mild to mod. COVID-19 in adults and pediatric […]
The US FDA has approved 4 NDAs and 1 BLA in Oct 2020, leading to treatments for patients and advances in the health care industry. […]
AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic […]
Regeneron’s coronavirus antibody cocktail therapy against COVID-19, famously used to treat president Donald Trump, has hit a safety issue after independent safety experts recommended it […]
Shots: Regeneron pauses dosing of the garetosmab (REGN2477) in the ongoing P-II LUMINA-1 study in patients with FOP. The pause is due to fatal serious […]
The FDA has started a priority review of Regeneron and Sanofi’s checkpoint inhibitor Libtayo in first-line non-small cell lung cancer (NSCLC), based on data they […]
Shots: The P-ll/lll trial involves assessing of REGN-COV2 (8gm/2.4gm) + SOC vs PBO + SOC in 524 patients with mild-to-moderate COVID-19 in an outpatient setting […]
Shots: Part A of P-lll study involves assessing of Dupixent (qw, 300mg) vs PBO in 81 patients aged≥ 12 yrs. with EoE. The study resulted […]
Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease Published: Oct 15, 2020 | Tags: approval, […]
An antibody cocktail from Regeneron has been approved by the FDA as the first treatment for Ebola, offering hope that a similar approach could be […]
Shots: The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers […]
Shots: Regeneron has submitted a request to the US FDA seeking EUA for its REGN-COV2 investigational Ab regimen to treat COVID-19. If EUA is granted, […]
Regeneron has followed Eli Lilly in asking the FDA for emergency approval of its COVID-19 antibody therapy, shortly after the drug was thrust into the […]
Eli Lilly has asked the FDA for an Emergency Use Authorization for its COVID-19 antibody therapy, after announcing new efficacy data from an ongoing trial. […]
GlaxoSmithKline and partner Vir Biotechnology are to expand a trial of an experimental antibody to treat COVID-19, putting heat on Regeneron’s rival that has been […]
Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout Published: Oct 1, 2020 | Tags: Chronic Refractory Gout, COMPARE […]
Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, […]
Roche has agreed to help Regeneron manufacture its COVID-19 antibody cocktail REGN-COV2, which started late-stage clinical testing a few weeks ago, in a deal that […]
Shots: The two global companies collaborated to develop, manufacture, and distribute REGN-COV2 across the globe. The agreement is expected to increase the supply of REGN-COV2 […]
The FDA has started a speedy review of Regeneron’s ANGPTL3-targeting antibody evinacumab for a rare, inherited disorder that dramatically raises the risk of heart disease. […]
Shots: The BLA is based on P-III study evaluating the efficacy and safety of evinacumab (15 mg/kg, IV, q4w) in 65 patients aged ≥12yrs. with […]
Regeneron and Sanofi’s PD-1 inhibitor Libtayo will be tested in tandem with a cancer vaccine developed by BioNTech in melanoma in people who have failed […]
Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has […]
Shots: Regeneron will be responsible to deliver treatment doses for six years post-approval of product from the FDA, will receive compensation of ~$10M & average […]
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