The FDA on Wednesday released new draft guidance spelling out exactly how it conducts therapeutic equivalence (TE) evaluations for generic and follow-on drugs.

The 14-page draft, which ends with 14 frequently asked questions related to TE, initially explains how the scientific and regulatory foundation for the evaluation of TE involves three main components: Pharmaceutical equivalence, bioequivalence, and establishing the same clinical effect and safety profile for the conditions of use as specified in the label.

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When gene editing exploded onto the scene over three decades ago, it brought previously inconceivable disease treatment and potentially curative therapies into view. Today, gene editing remains one of the most gripping topics in biopharma — and a recent wave of partnerships may move the industry even closer to broad, curative treatment for genetic disease.

Discoveries across the natural environment deriving in vivo and ex vivo biotechnologies have ushered a floodgate of development possibilities. With giants like Bayer, Moderna, Vertex and others signaling that gene editing will be a key driver of their future pipelines, how will the industry leverage this new frontier of genomic technology?

Roche CEO Severin Schwan will be moving to the board chairman role in a few months, making room for Thomas Schinecker — the current chief of the diagnostics division — to take the helm of the Swiss pharma conglomerate.

The changeover will take place at the company’s annual general meeting in March as Christoph Franz, chairman since 2014, decided not to seek re-election to the board.

The shuffle at the top comes as Roche has steadily beefed up its early-stage pipeline while vigilantly guarding its position as one of the top drugmakers around the world. By Evaluate’s estimate, it is set to rank second on the list of largest pharmas by 2028, falling just a tad behind AbbVie.

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How does a cancer drug cross the FDA finish line 3-5 months before its PDUFA date? That’s where the Real-Time Oncology Review comes in.

For the last five years, FDA’s Oncology Center of Excellence under Rick Pazdur has been quietly tapped into RTOR to allow sponsors to provide even earlier, segmented submissions of critical efficacy and safety data, thereby enabling these faster evaluations of applications.

Hiring has always been an issue for the FDA, particularly for those with expertise in pharma and biotech as they can quickly move over to the industry and earn double or triple what they make at the federal agency.

But a recent staff crunch and a surge in the turnover for quality operations inspectors at the FDA this year is becoming particularly noticeable for companies that rely on agency inspections to win approvals, even if the recent case of Novartis and BeiGene missing their PDUFA date due to an inspection was more of an issue with Chinese travel restrictions.

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With demand rising for Bavarian Nordic’s smallpox vaccine, European officials have given the thumbs up to expand the label to include monkeypox.

Imvanex, marketed as Jynneos in the US, has been approved in Europe to treat smallpox since 2013. On Friday, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended adding a monkeypox indication to the label, as global cases surge past 15,000. The label expansion still needs to be approved by the European Commission before it’s official.

As more and more biotechs are looking into the potential applications of using real-world evidence in regulatory submissions, the European Medicines Agency is calling for more widespread adoption.

EMA endorsed a statement published Friday by ICMRA, the International Coalition of Medicines Regulatory Authorities, highlighting the use of both RWE and real-world data in development and regulatory authorizations, noting their role

After Olympic gold medalist Lindsey Vonn’s first major knee surgery in 2013, she couldn’t sleep. That was the beginning of a cycle of more injuries, added anxiety and stress snowballing into an eventual diagnosis of insomnia.

Now Vonn’s teaming up with Idorsia Pharmaceuticals on its sleep drug Quvivic as its newest celebrity patient ambassador. Vonn appeared in media interviews this week, including on the Today Show and People magazine, talking about her struggles with sleep, along with overall mental health issues.

Lonza’s recent building spree and contracts have the manufacturer looking positive as it enters the second half of the year.

According to Lonza’s financial report for H1, which was released on Friday, the Swiss manufacturer posted sales of CHF 3 billion, or $3.1 billion, granting them a total of 16.8% growth in sales.

The first half’s core EBIDTA for Lonza also rose 33.1% according to the company. The company is still targeting low to mid-teen sales and EBIDTA growth for the year.

Sens. Cory Booker (D-NJ) and Rand Paul (R-KY) likely don’t share much in common when it comes to policy views, but that didn’t stop the pair from introducing a new bill this week that would alter the controversial Right to Try Act to allow terminally ill patients to access Schedule I drugs after a Phase I trial has been completed.

Building off its predecessor, the bill would skirt around the FDA’s expanded access program and the DEA’s regulations around controlled substances, and allow patients to potentially access Schedule I drugs — like MDMA and psilocybin — much more easily, as the senators say these drugs “have shown exceptional promise in treating a variety of mental health conditions, including suicidal depression, anxiety, and PTSD.”

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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