UPDATED: South Africa sidelines AstraZeneca’s vaccine after it failed to protect against new variant in a study, raising global alarms

February 8, 2021 07:31 AM ESTUpdated 09:48 AM

UPDATED: South Africa sidelines AstraZeneca's vaccine after it failed to protect against new variant in a study, raising global alarms

Nicole DeFeudis

Editor

South Africa is slamming the brakes on the rollout of AstraZeneca and Oxford University’s Covid-19 vaccine after data showed it did not protect against mild-to-moderate cases caused by the B.1.351 variant, which is now widespread in the country.

Professor Salim Abdool Karim, one of South Africa’s leading Covid-19 experts, told reporters in a briefing on Sunday that the country is putting a temporary hold on the administration of one million AstraZeneca vaccines that have already been delivered.

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MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

Innovative MedTech Demands Specialist Clinical Trial Regulatory Affairs and Design

Tom Avery

Scientific and Medical Affairs Specialist, Medical Devices

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Tony Coles, Cerevel CEO

August 11, 2022 07:26 AM EDT

Financing

Cerevel takes the public offering route, with a twist — raising big money thanks to rival data

Max Gelman

Senior Editor

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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August 10, 2022 08:25 AM EDT

Editor's note

Who are the women blazing trails in biopharma R&D? Nominate them for Endpoints' 2022 special report

Nicole DeFeudis

Editor

Amber Tong

Senior Editor

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

ENDPOINTS CAREERS

Chief Scientific Officer

Experimental Drug Development Centre

Singapore

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August 10, 2022 07:33 AM EDTUpdated 2 hours ago

Pharma

Updated: Amid massive restructuring, Biogen looks to reduce physical presence in Boston

Amber Tong

Senior Editor

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Bernat Olle, Vedanta Biosciences CEO

August 11, 2022 07:30 AM EDT

People

Citing 'challenging economic environment,' PhIII-ready microbiome biotech lays off 20% of staffers

Amber Tong

Senior Editor

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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Hervé Affagard, MaaT Pharma CEO

August 11, 2022 07:16 AM EDT

FDA+

One year into clinical hold, FDA has more questions about 'pooled' microbiome therapy

Amber Tong

Senior Editor

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

August 10, 2022 02:24 PM EDTUpdated 02:52 PM

Pharma

Pfizer launches rebate program for rare disease patients who have to stop taking Panzyga

Nicole DeFeudis

Editor

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

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Senior Project Manager

CAI

Boston, MA, USA

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Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

August 10, 2022 02:22 PM EDT

Pharma

Marketing

Horizon readies kids and families for back to school with weeklong activities around rare disease cystinosis

Beth Snyder Bulik

Senior Editor

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Alessandro Maselli, Catalent CEO

August 10, 2022 12:50 PM EDTUpdated 01:37 PM

Deals

Manufacturing

Catalent acquires North Carolina CDMO for $475M, boosting oral solids work

Tyler Patchen

News Reporter

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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