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Lilly and NIAID Halt COVID-19 Antibody Trial in Hospitalized Patients

Biospace news - Tue, 10/27/2020 - 02:00
Eli Lilly is continuing their other trial in mild-to-moderate COVID-19 patients and stated they “remain confident … that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19.”

Caris Life Sciences Secures $310 Million to Advance Precision Medicine Toolset

Biospace news - Tue, 10/27/2020 - 02:00
Molecular science company Caris Life Sciences secured $310 million in growth capital that will be used to expand its presence in precision medicine in oncology.

Kala Gets the Greenlight from FDA for Dry Eye Disease Treatment

Biospace news - Tue, 10/27/2020 - 02:00
EYSUVIS is the first FDA-approved ocular corticosteroid for the treatment of dry eye disease.

Singapore Halts Dosing of Two Flu Shots After 59 Deaths in South Korea

Biospace news - Tue, 10/27/2020 - 02:00
South Korea, on the other hand, indicated they would continue their state-run vaccination program because they did not find a direct link between the deaths and the vaccinations.

Biopharma Update on the Novel Coronavirus: October 27

Biospace news - Tue, 10/27/2020 - 02:00
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 27, 2020.

Some Manufacturing Sites for COVID-19 Vaccines Can Skip FDA Inspections

Biospace news - Tue, 10/27/2020 - 02:00
While pre-license inspections of manufacturing sites are typically done following the acceptance of a BLA filing, due to the public health emergency of COVID-19, the FDA is instead requiring a quality control unit to be established by each manufacturer with detailed report submissions about their...

CAR T Therapy Helps Toddler Emerge Victorious Over Infant Leukemia

Biospace news - Tue, 10/27/2020 - 02:00
Chasity’s story stands in hopeful defiance of a typically grim acute lymphocytic leukemia prognosis. In this case, CAR T cell therapy has proven to be a uniquely viable option.

Johnson & Johnson prepares to resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19 vaccine candidate in the U.S.

World Pharma News - Mon, 10/26/2020 - 16:00
Johnson & Johnson is preparing to resume recruitment in the pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine in the United States after a temporary pause.

The independent Data Safety and Monitoring Board (DSMB) overseeing the ENSEMBLE study has recommended resuming trial recruitment. Following consultation with the U.S. Food and Drug Administration (FDA), preparations to resume the trial in the United States, including submissions for approval by the Institutional Review Boards, are now underway.

Moderna announces supply agreement with the Ministry of Public Health to supply Qatar with mRNA vaccine against COVID-19 (mRNA-1273)

World Pharma News - Mon, 10/26/2020 - 13:00
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a supply agreement with the Ministry of Public Health of Qatar for mRNA-1273, Moderna's vaccine candidate against COVID-19, to support the Ministry's ongoing efforts to secure early access to a safe and effective COVID-19 vaccine for the people of Qatar.

COVID-19 containment shaped by strength, duration of natural, vaccine-induced immunity

World Pharma News - Mon, 10/26/2020 - 11:00
"Much of the discussion so far related to the future trajectory of COVID-19 has rightly been focused on the effects of seasonality and non-pharmaceutical interventions [NPIs], such as mask-wearing and physical distancing," said co-first author Chadi Saad-Roy, a Ph.D. candidate in Princeton's Lewis-Sigler Institute for Integrative Genomics.

Bayer Acquires AskBio for Up to $4 Billion to Expand Gene Therapy Platform

Biospace news - Mon, 10/26/2020 - 02:00
Bayer is paying $2 billion upfront for AskBio's AAV-based gene therapy pipeline of treatments for Pompe disease, among others, and could pay an additional $2 billion in potential milestones.

AstraZeneca's COVID-19 Vaccine Boosts Immune Response in Older, Younger Adults

Biospace news - Mon, 10/26/2020 - 02:00
Days after the U.S. FDA greenlit the restart of AstraZeneca’s Phase III COVID-19 vaccine trial, the company said the preventative medication boosts immune responses in older and younger adults against the novel coronavirus.

Novartis' Most Advanced Kidney Compound Shows Promise in C3G

Biospace news - Mon, 10/26/2020 - 02:00
Novartis released promising interim Phase II data of iptacopan in C3 glomerulopathy (C3G). The analysis was presented at the virtual American Society of Nephrology (ASN) 2020 Annual Meeting.

Spectrum Pharmaceuticals Sees Delay from FDA on Eflapegrastim BLA

Biospace news - Mon, 10/26/2020 - 02:00
"We are actively working with the FDA to find a way to expedite the plant inspection," said Joe Turgeon, president and CEO of Spectrum Pharmaceuticals. "The manufacturing facility is ready for inspection and we are eager to assist the FDA in completing their assessment as soon as possible."

FORMA Therapeutics’ Olutasidenib Shows Promising Activity Against IDH1-Mutated AML

Biospace news - Mon, 10/26/2020 - 02:00
Treatment with FORMA Therapeutics’ investigational agent olutasidenib has shown promising efficacy and safety in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and mutations in isocitrate dehydrogenase 1 (IDH1m).

Clinical Catch-Up: October 19-23

Biospace news - Mon, 10/26/2020 - 02:00
It was another busy week for clinical trial updates and news. Here’s a look.

FibroGen Provides More Support for Roxadustat in Anemia Associated with Kidney Disease

Biospace news - Mon, 10/26/2020 - 02:00
FibroGen presented data from two pooled analyses from its roxadustat global Phase III development program this weekend at the American Society of Nephrology Kidney Week 2020 Reimagined conference.

FDA authorises restart of the COVID-19 AZD1222 vaccine US Phase III trial

World Pharma News - Sat, 10/24/2020 - 10:00
Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed across the world with regulators in the US, UK, Brazil, South Africa and Japan confirming that it was safe to do so.

The Food and Drug Administration (FDA) authorised the restart in the US, following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial.

CureVac reports positive preclinical data for its COVID-19 vaccine candidate, CVnCoV

World Pharma News - Fri, 10/23/2020 - 12:00
CureVac N.V. (Nasdaq: CVAC), a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid ("mRNA"), today announced data from preclinical studies of its investigational SARS-CoV-2 vaccine candidate, CVnCoV, in mice and hamsters. The vaccine candidate elicited balanced humoral and cellular immune responses, featuring high antibody titers and very good T cell activation.

FDA Greenlights Restart of AstraZeneca’s Phase III COVID-19 Vaccine Study

Biospace news - Fri, 10/23/2020 - 02:00
After nearly a month in limbo, AstraZeneca will resume Phase III testing of its COVID-19 vaccine candidate in the United States.