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Thursday, December 17, 2020
Glaxo Benlysta Gets FDA Approval for Lupus Nephritis
EU Eyes Late-December Covid-19 Vaccine Rollout
The European Union intends to start vaccinating citizens against Covid-19 as soon as Dec. 27, days after its planned decision on whether to authorize Pfizer Inc. and BioNTech SE's shot.
The bloc has been criticized over the pace of its regulatory review of the Pfizer-BioNTech vaccine, which is already being administered in the U.S., U.K., Canada and Saudi Arabia, despite being developed in Germany, an EU member.
European Commission President Ursula von der Leyen tweeted Thursday that a vaccine rollout would begin in the 27-country bloc on Dec. 27, 28 and 29. A spokesman for Mrs. von der Leyen later noted that the rollout date was conditional on approval from the EU's top drugs regulator, the European Medicines Agency.
Earlier this week, the EMA said it would advance its review of the Pfizer-BioNTech vaccine after coming under pressure from some governments, setting a new date of Dec. 21 to decide on whether to authorize it.
EMA officials have said they are moving as fast as they can without eroding trust in vaccines. Some health officials and medical institutions have warned that hasty authorization of a shot that uses novel technology would be a difficult sell on a continent where overall vaccination rates have declined.
EU officials have said their goal is for vaccinations to begin in all of the bloc's countries on the same day.
Saudi Arabia began inoculating its citizens and residents Thursday, rolling out the Pfizer-BioNTech vaccine after receiving two initial shipments.
Health Minister Tawfiq al-Rabiah rolled up the sleeve of his traditional white robe to receive a jab on live television as part of a government effort to encourage people to get vaccinated.
"During the past nine months I was anxiously tracking the number of cases," Mr. Rabiah told reporters. "Today I will begin happily tracking the number of vaccinations."
The coronavirus has sickened more than 360,000 people in Saudi Arabia, more than 6,000 of whom have died, according to government reporting.
More than 150,000 Saudis have already registered via a phone app to get the shot, which the country is offering free to everyone over age 16, even those who have recovered from the illness.
Also Thursday, New Zealand said it had secured deals secured deals with two more vaccine makers, giving it enough shots to begin inoculating the entire country from the second quarter of next year.
The latest agreements with AstraZeneca PLC and Novavax Inc. would cover more than nine million people if the vaccines are approved by New Zealand's regulators. The government had previously struck deals with Janssen Pharmaceutica, Pfizer and BioNTech.
New Zealand, a country of fewer than five million, has now ordered enough vaccines to cover 15 million people to allow for the possibility that some of the shots don't succeed in the final phase of clinical testing.
The country plans to begin vaccinating those working at the border and in health care in the second quarter, and the general public the following quarter.
The nation is under less pressure than other countries to distribute vaccines, having successfully contained the spread of Covid-19, aided by its island geography and one of the strictest lockdowns in the world.
The government said border controls, which require all arrivals to quarantine for two weeks, won't change until there is confidence the vaccinations are providing sufficient protection.
Aldeyra launches multiple mid-stage trials to evaluate ADX-629
- Aldeyra Therapeutics (NASDAQ:ALDX) has initiated Phase 2 trials of ADX-629, a reactive aldehyde species inhibitor, for the treatment of COVID-19, atopic asthma, and psoriasis as part of a systematic strategy to assess activity across different types of immunological diseases.
- In April, it disclosed Phase 1 data in 85 healthy volunteers that showed ADX-629 was well-tolerated with no treatment-related adverse events observed with clinically relevant plasma concentrations. Reductions in pro-inflammatory RASP malondialdehyde was noted in treated participants.
- COVID-19 Phase 2 will evaluate the safety, tolerability, efficacy, and pharmacodynamics of ADX-629 in ~30 adult patients. The FDA signed off the study in September, and enrollment is expected to begin by year-end.
- Atopic Asthma Phase 2 trial in 12 subjects, outcomes will include pulmonary function testing following allergen and methacholine challenge, sputum eosinophil counts, and plasma levels of cytokines and RASP. Enrollment is expected to begin in Q1 of 2021.
- Psoriasis study in 10 patients will evaluate severity index, skin cytokine transcription profiles, plasma leukocyte cytokine release following endotoxin-challenge, and plasma levels of cytokines and RASP. Enrollment is expected to begin 1H of 2021.
- https://seekingalpha.com/news/3645328-aldeyra-launches-multiple-mid-stage-trials-to-evaluate-adxminus-629
Moderna’s COVID-19 vaccine under expert panel review
- The expert panel evaluating the COVID-19 vaccine candidate from Moderna (NASDAQ:MRNA) has started the proceedings.
- The meeting by the Vaccines and Related Biological Products Advisory Committee will run until 5:15 p.m.ET with a vote, that typically happens towards the end of the meeting, potentially clearing the way for Moderna to seek the emergency authorization from the FDA.
- Last week, the expert panel voted 17 to 4 to recommend the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX), with the FDA granting the EUA a day later. Though the FDA is not bound by the recommendation, it often follows the guidance.
- Packaged and delivered by McKesson (NYSE:MCK), nearly 6 million doses of Moderna’s vaccine will reach 3,285 sites in the U.S. following the approval, according to officials.
- Moderna’s briefing documents filed earlier this week included data showing the vaccine’s first dose had yielded efficacy in preventing asymptomatic infection, a vital characteristic to contain the pandemic.
- A researcher from Pfizer had said last week its vaccine’s ability to prevent asymptomatic cases was under investigation, and the analysis could be complete in early 2021.
- The prevention of asymptomatic cases will be vital to contain the pandemic that has so far claimed more than 300,000 lives in the U.S.
- https://seekingalpha.com/news/3645334-moderna-s-covidminus-19-vaccine-goes-under-review
Evolus updates on U.S. ITC case related to Jeuveau
- The U.S. International Trade Commission (ITC) has issued its final determination in the action brought by Allergan and Medytox against Evolus (NASDAQ:EOLS) and Daewoong.
- In its notice, the ITC affirmed in part the initial determination of the Administrative Law Judge (ALJ) finding a violation of Section 337 of the Tariff Act of 1930 as it relates to certain manufacturing processes.
- However, the ITC reversed the ALJ’s finding that a trade secret exists with respect to Medytox’s bacterial strain. The Commission issued orders preventing the import, sale and marketing of Jeuveau in the U.S. for 21 months, reduced from the 10-year recommendation in July 2020.
- The decision is not final until the 60-day presidential review period is complete during which, the Company plans to fund a bond to allow for the continued sales and marketing of Jeuveau in the U.S.
- Jeuveau is a registered trademark of Evolus.
- https://seekingalpha.com/news/3645184-evolus-updates-on-u-s-itc-case-related-to-jeuveau-sales-and-marketing
Novartis to acquire neuroscience firm Cadent Therapeutics for up to $770M
- Novartis (NYSE:NVS) and privately held Cadent Therapeutics have entered into a definitive agreement under which Novartis will acquire all of the outstanding capital stock of Cadent Therapeutics.
- The acquisition will give Novartis full rights to Cadent’s neuroscience portfolio, including its NMDAr program, consisting of two clinical programs: CAD-9303 and MIJ-821, which was licensed to Novartis in 2015.
- Additionally, Novartis will gain full rights to CAD-1883, a clinical stage SK channel positive allosteric modulator in development for movement disorders.
- Upon the closing of transaction, Cadent will receive a $210M upfront payment and will be eligible for up to $560M in milestone payments, for a total potential consideration of $770M.
- The transaction is expected to close during Q1 2021.
- https://seekingalpha.com/news/3645200-novartis-to-acquire-neuroscience-firm-cadent-therapeutics-for-up-to-770m
FDA accepts Merck's application for Keytruda + chemo in esophageal cancer
- Under Priority Review status, the FDA has accepted Merck's (NYSE:MRK) new supplemental Biologics License Application (sBLA) for KEYTRUDA, an anti-PD-1 therapy, in combination with platinum and fluoropyrimidine based chemotherapy for the first-line treatment of patients with carcinoma of the esophagus and gastroesophageal junction (GEJ).
- The PDUFA, or target action date is set to April 13, 2021.
- https://seekingalpha.com/news/3645215-fda-accepts-mercks-application-for-keytruda-chemotherapy-in-esophageal-cancer
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