John Nkengasong, Africa CDC director (Andre Pain/AFP via Getty Images)

Covid-19 roundup: Africa CDC to seek vac­cine do­na­tion pause — re­port; New study sug­gests blood clots from As­traZeneca shot are very rare

The Africa CDC is re­port­ed­ly seek­ing a pause in vac­cine do­na­tions as lo­gis­ti­cal chal­lenges and hes­i­tan­cy be­gin to out­strip sup­ply is­sues.

John Nken­ga­song, the agency’s di­rec­tor, told Politi­co on Tues­day that coun­tries are bet­ter able to pro­vide shots for their cit­i­zens. But con­cerns over get­ting shots in­to arms have mount­ed in re­cent weeks, and the con­ti­nent’s CDC will ask for a do­na­tions pause un­til the third or fourth quar­ter this year.

Nken­ga­song rea­soned the vac­cines would ex­pire if oth­er coun­tries and CO­V­AX con­tin­ued the pace of its cur­rent ship­ments.

“It’s like buy­ing a whole bas­ket of foods and just to put it on your kitchen counter,” he told Politi­co. “If you can­not use any, it will rot. But if you do that in small­er pieces, then you still get to the end goal with the same amount of food on your kitchen ta­ble — but at least you don’t have any waste.”

Most of the con­ti­nent’s vac­cine hes­i­tan­cy comes from young in­di­vid­u­als who don’t see the virus as much of a threat, he added. In ad­di­tion, he list­ed the fol­low­ing lo­gis­ti­cal chal­lenges: African coun­tries still need to build up their cold-stor­age ca­pac­i­ties, make more sup­plies like sy­ringes and nee­dles avail­able, and fig­ure out where to store un­used shots.

Thus far, CO­V­AX says it has shipped more than 500 mil­lion Covid-19 vac­cine dos­es to low-in­come coun­tries, many of which are in Africa. The Africa CDC’s strat­e­gy al­so comes as Pres­i­dent Joe Biden aims to boost US vac­cine do­na­tions to oth­er coun­tries as the Omi­cron wave sub­sides state­side.

New study shows blood clot risk is ex­treme­ly low af­ter As­traZeneca shot 

A new study from the UK is delv­ing deep­er in­to side ef­fects from the As­traZeneca vac­cine, sug­gest­ing events of rare blood clots may be more un­com­mon than pre­vi­ous­ly thought.

Re­searchers found the clots on­ly ap­peared in one case per three mil­lion vac­ci­na­tions, and on­ly af­ter in­di­vid­u­als re­ceived their first dose, ac­cord­ing to a pa­per pub­lished in PLOS Med­i­cine. The study an­a­lyzed health records of 46 mil­lion Eng­lish adults be­tween De­cem­ber 2020 and March 2021 to draw its con­clu­sions.

The pa­per’s au­thors looked specif­i­cal­ly at in­tracra­nial ve­nous throm­bo­sis (ICVT) and throm­bo­cy­tope­nia, or clots that are some­times ac­com­pa­nied by low platelet counts. Some coun­tries sus­pend­ed roll­outs of the As­traZeneca vac­cine when these is­sues first arose in ear­ly 2021.

Tues­day’s study showed no risk of blood clots for those old­er than 70, with younger pop­u­la­tions see­ing high­er risk. For all pop­u­la­tions, the au­thors said the risk of blood clots “are like­ly to be out­weighed” by the shot’s ben­e­fits in pro­tect­ing against Covid-19 hos­pi­tal­iza­tion and death.

It’s the same side ef­fect that in­duced a dis­tri­b­u­tion pause in the US for the J&J vac­cine last April. Though ad­min­is­tra­tion re­sumed a few weeks lat­er fol­low­ing a re­view clear­ing the shot, the pause damp­ened vac­cine up­take at the time, par­tic­u­lar­ly for the J&J shot. As­traZeneca and J&J used the same tech­nol­o­gy in de­vel­op­ing their vac­cines — ade­n­ovi­ral vec­tors.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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‘Catchy’ de­sign tops big ad buys on­line for grab­bing on­col­o­gists’ at­ten­tion — sur­vey

The cancer drug ads that get oncologists’ attention online are informative and use clear, eye-catching designs. That’s ZoomRx’s assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions.

One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors.

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