- Medical Design Sourcing

The Bothell, Wash.–based clinical-stage biopharma Athira Pharma (NSDQ:ATHA) is in a tailspin after the company’s board put Leen Kawas, the firm’s CEO, on temporary leave.

The company’s stock closed the day at an all-time low of $11.15. The stock was valued as high as $34.25 on Dec. 31, 2020.

Washington State University has launched an independent review of Kawas’s doctoral research in molecular pharmacology and toxicology, which she completed a decade ago.

The university is investigating reports that Kawas authored several papers with altered images.

Get the full story from our sister site, Drug Discovery & Development.

Athira Pharma’s stock falls 39% after placing its CEO on leave

The Bothell, Wash.–based clinical-stage biopharma Athira Pharma (NSDQ:ATHA) is in a tailspin after the company’s board put Leen Kawas, the firm’s CEO, on temporary leave.

The company’s stock closed the day at an all-time low of $11.15. The stock was valued as high as $34.25 on Dec. 31, 2020.

Washington State University has launched an independent review of Kawas’s doctoral research in molecular pharmacology and toxicology, which she completed a decade ago.

The university is investigating reports that Kawas authored several papers with altered images.

Several papers Kawas had co-authored now appear on PubPeer, which cites possible problems with published research. PubPeer authors have pointed out that specific images in those papers appear to have duplicated portions and other irregularities. Some of the anomalies could have led to incorrect research findings or at least the interpretability of those findings.

In the interim, the company has…

Moderna to expand its Massachusetts manufacturing capabilities

Cambridge, Mass.–headquartered Moderna (NSDQ:MRNA) will hire at least 155 new manufacturing employees for manufacturing jobs at its plant in Norwood, Mass.

A $2.33 million tax incentive from the Massachusetts Life Sciences Center helped bankroll the expansion. The investment will enable the company to double the size of its manufacturing site in Norwood, Mass., which became operational in 2018.

With limited manufacturing capability, Moderna has had to rely on partners with contract manufacturers such as Lonza(SWX:LONN), Catalent (NYSE: CTLT), Baxter BioPharma Solutions (NYSE: BAX), Recipharm and Laboratorios Farmacéuticos Rovi (BME:ROVI).

Get the full story from our sister site, Pharmaceutical Processing World.

Moderna to expand its Massachusetts manufacturing capabilities

Cambridge, Mass.–headquartered Moderna (NSDQ:MRNA) will hire at least 155 new manufacturing employees for manufacturing jobs at its plant in Norwood, Mass.

With limited manufacturing capability, Moderna has had to rely on partners with contract manufacturers such as Lonza (SWX:LONN), Catalent (NYSE: CTLT), Baxter BioPharma Solutions (NYSE: BAX), Recipharm and Laboratorios Farmacéuticos Rovi (BME:ROVI).

COVID-19 vaccine sales are fueling more growth. The company anticipates that it will generate $19.2 billion in revenue this year. That level of revenue would likely catapult the company into the top 20 pharmaceutical companies. For context, the top two pharma companies had approximately $50 billion in revenue in 2020.<…

Senator Manchin asks Biden to oust Woodcock over Aduhelm row

The West Virginia Senator Joe Manchin III (D-W. Va) sent a letter to President Joe Biden expressing his dismay regarding the FDA’s approval of Aduhelm (aducanumab), the controversial Alzheimer’s treatment from Biogen (NSDQ:BIIB).

The nonprofit watchdog group Public Citizen sent a broadly similar letter to HHS Secretary Xavier Becerra to “express its outrage” over the approval and to demand the resignations from prominent FDA officials.

Get the full story from our sister site, Pharmaceutical Processing World.

Senator Manchin asks Biden to oust Woodcock over Aduhelm row

Manchin also voiced concerns about the ongoing lack of permanent leadership as Dr. Janet Woodcock continues to serve as acting commissioner of the agency. Woodcock began her tenure as acting commissioner after Biden’s inauguration. She has worked at the agency since 1986.

Manchin asked Biden to make the FDA explain why it chose to ignore the advice of an external advisory committee, which had recommended that the agency not approve the drug without additional data.

Three members of that advisory committee have since…

Latest iCad 3D mammography AI gains CE mark

iCad’s latest AI for digital breast tomosynthesis provides a case score for each detection. (Image courtesy of iCad)

iCad (NSDQ:ICAD) today announced that the third version of its ProFound AI for digital breast tomosynthesis (DBT) has won CE mark approval.

Compared with previous software versions, the latest generation of ProFound AI offers up to a 10% improvement in specificity performance while maintaining a high sensitivity level, and approximately 40% faster processing on the new PowerLook platform, according to the Nashua, N.H.–based company.

Get the full story on our sister site, Medical Design & Outsourcing

Spino Modulation vertebral body tethering device wins FDA breakthrough device designation

Spinologics’s Spino Modulation today announced that it received FDA breakthrough device designation for its MIScoli vertebral body tethering device.

Spino Modulation designed the system to treat scoliosis in young adolescents.

Vertebral body tethering (VBT) is a less invasive alternative to spine fusion, which is the standard of care for adolescents who need surgery to correct a curvature of the spine. According to the company, MIScoli is one of a few VBT devices under investigation or limited market release in many countries.

Spinologics is performing an ongoing clinical trial to research the MIScoli system as a treatment option for idiopathic scoliosis to reduce deformity and prevent its worsening in growing children who are at high risk for curve progression while also preserving motion.

Contract manufacturers fuel medtech expansion in Costa Rica

Medical device manufacturing is flourishing in the Central American country, spurred by a host of incentives.

[Image from Unsplash]This year is seeing a wave of expansions by medtech contract manufacturers in Costa Rica.

Medtech OEMs have made the Central American company a manufacturing hub since the 1990s. Major companies operating there include Abbott, Bayer, Boston Scientific, Cardinal Health, Edwards Lifesciences, Hologic, Medtronic, Philips, Smith+Nephew and Wright Medical. Eight of these are among the top 20 exporters in Costa Rica, representing nearly $2.7 million in medical device exports in 2019 — 73% of the total.

Medtech OEMs in Costa Rica want their suppliers nearby, making the Central American country a magnet for contract manufacturers. The addition of medtech sterilization facilities in Costa Rica — BeamOne (now Steris) in 2009 and Sterigenics in 2013 — also helped spur more contract manufacturing. Before that, manufacturers had to ship prod…

Sepha unveils high performance leak tester for pharma packaging testing

Leak-testing and packaging specialist Sepha (Belfast) is launching a leak tester for container closure integrity testing (CCIT) applications that can detect leaks as small as 1 µm.

Known as the Multi-Q HD, the device supports the non-destructive detection of defects in pharmaceutical containers including parenteral packaging formats, which have experienced growth during the pandemic, thanks to mass-vaccination campaigns.

Even micro cracks and pinholes can negatively impact the shelf life and product efficacy of a range of pharmaceuticals. In terms of parenteral packaging, the Multi-Q HD supports a range of formats including glass or plastic vials, ampules, pre-filled syringes, bottles and blow-fill-seal containers.

Sepha Managing Director Paul Smith noted in a press release that the historic benchmark for CCIT had been 5 μm, but the industry has pushed to “raise the bar for increased integrity test sensitivity.” The trend has only accelerated during the …

Assessing pharma headwinds and tailwinds in mid-2021

Pfizer-BioNTech COVID-19 vaccine. Image courtesy of Wikimedia Commons.

Now that we have passed the year’s midway mark, pharma continues to be in a unique position.

While COVID-19 gave the industry an opportunity for a reputational reset in 2020, the pandemic is now a net positive for the industry, according to the recent Moody’s report, “Solid demand, lift from COVID-19 products continue to drive positive outlook.”

While demand for COVID-19 vaccines has ebbed recently in the U.S., Moody’s projects strong vaccine sales overall for the remainder of 2021. Pfizer (NYSE:PFE) upped their guidance for vaccine sales to $26 billion in their first-quarter earnings report. “Their approach to guidance for revenue is based on contracts that have been signed,” said Michael Levesque, lead author of the report. Thus, any future contracts that Pfizer signs after that guidance update will further expand their guidance …

mRNA vaccines do not negatively affect sperm county, study finds

One of the many urban legends related to COVID-19 vaccines is that they cause infertility. Researchers at the University of Miami set out to disprove that claim with a recent single-center prospective study. Unsurprisingly, the study that indicated the mRNA vaccines have no negative impact on male fertility. In fact, the researchers found that after the second vaccine dose, participants exhibited a significant increase in median sperm concentration and sperm motility.

In the study published in JAMA, the researchers stopped short of claiming that mRNA COVID-19 vaccines could boost fertility in men. “While these results showed statistically significant increases in all sperm parameters, the magnitude of change is within normal individual variation,” the study authors concluded.

The study only evaluated the BNT162b2 and mRNA-1273 vaccines from Pfizer-BioNTech and Moderna, respectively.

The study tracked participants approximately 70 days after administering…

What medtech’s top executives learned from their dads

[Image from Pixabay]For better or worse, parents including dads play a major role in who we become. As we approach Father’s Day in the U.S., MassDevice and MDO reached out to some of medtech’s top executives to ask what they learned from their dads.

Go to our sister site Medical Design & Outsourcing to read what they said.

What medtech’s top executives learned from their dads

[Image from Pixabay]

For better or worse, parents including dads play a major role in who we become. As we approach Father’s Day in the U.S., Medical Design & Outsourcing and MassDevice reached out to some of medtech’s top executives to ask what they learned from their dads.

Here’s what they said:

“My father built a business in the defense technology sector with some long-term colleagues as co-founders. Around the dinner table and over coffee for years, we’ve discussed the need for leadership excellence, technology excellence and empathy in bringing science-based business to the market. What a wonderful stroke of luck to have him in my life.” – Gary S. Guthart, CEO of Intuitive

Medtronic CEO Geoff Martha’s father, during his young days. [Image courtesy of Medtronic]

“My Dad has always been a strong s…

Glaukos wins Australian regulatory approval for MicroShunt

Glaukos (NYSE:GKOS) recently announced that it received regulatory approval from Australia’s Therapeutic Goods Administration for its Preserflo MicroShunt.

The San Clemente, Calif.-based company designed the MicroShunt to reduce intraocular pressure in the eyes of patients who have primary open-angle glaucoma where IOP remains uncontrollable or where glaucoma progression needs surgery.

Get the full story on our sister site, Medical Tubing + Extrusion.

CureVac marches on after announced disappointing study results

After CureVac (NSDQ:CVAC) revealed that its first-generation vaccine candidate has an interim efficacy of 47% in a pivotal trial, its stock lost about half its value. The company, however, is undeterred.

Speaking in a call with investors and analysts, CureVac CEO Franz-Werner Haas said the company would continue to seek the authorization of its CVnCoV vaccine and continue developing its next-generation CV2CoV vaccine.

One difference between the vaccine from CureVac and those from Moderna and Pfizer-BioNTech lies in the dose of mRNA. The CureVac vaccine contains 12 µg of mRNA per dose. The Pfizer-BioNTech vaccine uses 30 µg per shot, while the Moderna vaccine contains 100 µg.

Haas, however, stressed the role of virus variants in the 47% interim efficacy figure. The Phase 2b/3 study “provides important insights into a dramatically transformed variant environment, suggesting that we are virtually fighting a different virus — a different pandemic” than six m…

U.S. buys 200 million more Moderna vaccine doses for potential boosters and use in children

Health experts remain divided over the need for COVID-19 vaccine boosters in the coming months, but the U.S. government is preparing for that possibility by purchasing 200 million additional doses of the COVID-19 vaccine from Moderna (NSDQ:MRNA).

The purchase of additional doses will also enable the U.S. government to inoculate children aged 12 to 17 in coming months, assuming FDA authorizes that use. Two doses of the vaccine were 100% effective in that age group, according to a recent Phase 2/3 trial.

In May, FDA amended its EUA for the Pfizer-BioNTech vaccine to include adolescents aged 12 to 15.

The U.S. has committed to buying 500 million doses of Moderna’s vaccine to date. The company expects to deliver 110 million doses in the fourth quarter of 2021 and another 90 million in the first quarter of 2022.

To date, Moderna has provided 217 million doses to the U.S.

The NIH has launched a clinical trial involving fully vaccinated participan…

Biogen’s gosuranemab fails in Phase 2 study

Biogen (NSDQ: BIIB) has scrapped its development plans for gosuranemab (BIIB092) after the drug candidate failed to hit the primary endpoint in a Phase 2 trial.

Biogen’s aducanumab made waves recently, becoming the first Alzheimer’s drug to win FDA approval in recent memory. Not all, however, are happy with that fact.

Aducanumab is an amyloid beta-protein inhibitor while gosuranemab was an anti-tau antibody.

In the TANGO Study, gosuranemab did not appear to have a treatment benefit in several measures in the 78-week study. Such measures included the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog 13), the Alzheimer Disease Cooperative Study Activity of Daily Living (ADCS-ADL), the Mini-Mental State Examination (MMSE) and the Functional Assessment Questionnaire (FAQ).

Biogen will present the findings from the gosuranemab study at an upcoming medical congress.

The biotech iPierian first developed the antibody, whic…

Supreme Court upholds Affordable Care Act again

The front of U.S. Supreme Court in Washington, D.C. (Adobe stock photo)

The U.S. Supreme Court has turned back a third Republican challenge to the Affordable Care Act (ACA), this time by a 7-2 vote.

The latest challenge to the law popularly known as Obamacare came from Texas and other states, backed by the administration of former President Donald Trump. The justices ruled that the challengers lacked legal standing for their case. They did not address part of the law known as the “individual mandate,” which requires Americans to have health insurance and which the complainants sought to overturn as unconstitutional.

Get the full story on our sister site, Medical Design & Outsourcing.

Biden administration invests $3B to accelerate development of next-gen COVID-19 treatments

President Joe Biden [Image courtesy of the White House]President Joe Biden’s administration will spend $3 billion in American Rescue Plan money to accelerate the discovery, development and manufacturing of antiviral medicines against COVID-19, HHS announced today.

Not only will the Antiviral Program for Pandemics seek to boost the availability of medicines to prevent serious COVID-19 illness and save lives, but it will pursue sustainable discovery and development platforms that could produce antivirals against future viruses that threaten to spark pandemics.

Get the full story on our sister site Drug Discovery & Development.

Biden administration invests $3B to accelerate development of next-gen COVID-19 treatments

[Image courtesy of Biden for President]

President Joe Biden’s administration will spend $3 billion in American Rescue Plan money to accelerate the discovery, development and manufacturing of antiviral medicines against COVID-19, HHS announced today.

The program is a collaboration within the U.S. Department of Health and Human Services (HHS) that includes the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID) — and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness …

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