Stanley Erck, Novavax CEO (AP Images)

No­vavax takes pro­tein-based Covid-19 vac­cine over­seas, ask­ing for an ap­proval in the UK

Just af­ter an on­slaught of man­u­fac­tur­ing is­sues last week and sub­mit­ting their Covid-19 vac­cine to the WHO for re­view last month, No­vavax is go­ing across the sea and tak­ing its pro­tein-based Covid-19 vac­cine up with the crown.

The com­pa­ny filed for mar­ket­ing au­tho­riza­tion ap­proval with the MHRA in the UK, No­vavax said this morn­ing in a state­ment.

As for a sub­mis­sion to the FDA, No­vavax said that they plan to have the ap­pli­ca­tion in by year’s end. The Mary­land biotech has de­layed fil­ing with the FDA sev­er­al times, spark­ing crit­i­cism from an­a­lysts as cred­i­bil­i­ty has worn thin.

The biotech had re­ceived close to $1.6 bil­lion last year from the feds for its work on the vac­cine, as the Trump ad­min­is­tra­tion pledged to buy 100 mil­lion dos­es in Op­er­a­tion Warp Speed.

Shares of No­vavax $NVAX rose about 8% to $146.30 over the day.

The re­quest in the UK for a go-ahead is based on da­ta from close to 45,000 pa­tients in Phase III tri­als.

No­vavax and its man­u­fac­tur­ing part­ner in In­dia — the Serum In­sti­tute — have al­ready filed for au­tho­riza­tion in In­dia, In­done­sia and the Philip­pines, and re­quest­ed an emer­gency use list­ing with WHO.

Through that arrange­ment, No­vavax and Serum are ex­pect­ed to de­liv­er more than a bil­lion dos­es — but that is on­ly pos­si­ble if No­vavax gets all its man­u­fac­tur­ing is­sues squared away.

Just last week, news broke that pro­duc­tion prob­lems at a fa­cil­i­ty in Mary­land could lead to a short­age of as many as 1 bil­lion dos­es.

The com­pa­ny has run in­to trou­ble with the pu­ri­ty of its vac­cine, with the biotech hav­ing trou­ble prov­ing it can con­sis­tent­ly pro­duce a shot up to agency’s stan­dards, and it has caused sig­nif­i­cant de­lays in the roll­out to low- and mid­dle-in­come coun­tries. This fol­lows sev­er­al de­lays at No­vavax that has put ex­ec­u­tives on the de­fen­sive.

Ac­cord­ing to sources who spoke with Politi­co, pu­ri­ty lev­els in the vac­cine have hov­ered at around 70%. And be­cause low­er pu­ri­ty lev­els raise the chance of hav­ing con­t­a­m­i­nants or un­nec­es­sary sub­stances in the vac­cine, that can dis­rupt plans to get vac­cine sup­plies more broad­ly dis­trib­uted.

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

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.

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

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.

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

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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Hervé Affagard, MaaT Pharma CEO

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

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).

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

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.

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

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

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

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

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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Phar­mas spend mil­lions on di­a­betes ad­ver­tis­ing, but few pa­tients can re­call brand names — sur­vey

While many Big Pharma diabetes brands spend millions of dollars on TV ads every year, most people with type 2 diabetes don’t recognize specific drug brand names, according to a new study.

No brand garnered more than 30% recognition in Phreesia Life Science’s latest in-office patient survey of more than 4,000 adults with type 2 diabetes. Eli Lilly’s Trulicity topped the list as the most recognized brand with 29% of those surveyed recalling it, followed by Boehringer Ingelheim and Lilly’s Jardiance at 27% and Merck’s Januvia and Novo Nordisk tying for the third spot with 24%. Meanwhile, 76% of the patients surveyed were familiar with the generic treatment metformin.

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Faced with thou­sands of opi­oid law­suits, En­do says it will like­ly file for bank­rupt­cy 'im­mi­nent­ly'

Endo International will likely be the next pharma company to file for bankruptcy under a mountain of opioid lawsuits.

The Dublin, Ireland-based company revealed in its Q2 results on Tuesday that it’s in talks with first lien creditors, and that “these negotiations will likely result in a pre-arranged filing under Chapter 11 of the U.S. Bankruptcy Code by Endo International plc and substantially all of its subsidiaries, which could occur imminently.”