Euro meds regulator moves up Moderna vaccine review date

 Europe’s medicines regulator on Thursday set up an exceptional meeting for Jan. 6 to assess a marketing authorisation application for Moderna’s COVID-19 vaccine.

The European Medicines Agency (EMA) had earlier planned to meet on Jan. 12 to review the application.

“Today, ahead of schedule, (Moderna) has submitted the last outstanding data package needed for the assessment of the application. This contains information that is specific to the manufacturing of the vaccine for the EU market,” the EMA said.

The regulator had said on Tuesday that an expert panel would convene on Dec. 21 to evaluate the vaccine made by U.S. company Pfizer and German partner BioNTech. It had previously said the meeting could be as late as Dec 29.

https://www.reuters.com/article/us-health-coronavirus-europe-moderna/european-medicines-regulator-brings-forward-modernas-vaccine-review-date-idUSKBN28R2Q7

Novavax surges after winning new order for COVID-19 vaccine

 

• Novavax (NASDAQ:NVAX) climbs +9.2% after announcing an agreement to supply 10.7M doses of its COVID-19 vaccine to the government of New Zealand.
• Per the agreement, the company is set to deliver the initial doses of the vaccine candidate, NVX-CoV2373, from mid-2021, subject to the approval of Medsafe, New Zealand’s regulatory agency.
• The recombinant protein vaccine adjuvanted with Novavax’ proprietary Matrix-M™ to boost the immune response against COVID-19 is currently undergoing a Phase 3 clinical trial in the UK.
• On the back of COVID-19 vaccine success, Novavax has surged a whopping 2930% during the year, far eclipsing the performance of front-runners, Moderna (NASDAQ:MRNA), Pfizer (NYSE:PFE), and BioNTech (NASDAQ:BNTX).
• https://seekingalpha.com/news/3645472-novavax-surges-9-after-winning-new-order-for-covidminus-19-vaccine

Arbutus initiated at Buy at H.C. Wainwright on likely stock catalyst AB-720

 

• Arbutus Biopharma (ABUS +3.4%) was initiated with a Buy rating at H.C. Wainwright, PT $10.
• Analyst Ed Arce mentions that company is unique as an hepatitis B virus pure-play given that its management has designed and assembled a broad, proprietary portfolio.
• He further sees momentum building for AB-729, with "more definitive, positive" multi-dose data in Q1 "likely to represent a significant stock catalyst.
• As of Sep.30, 2020, cash balance stood at $118.3M; cash runway into mid-2022.
• https://seekingalpha.com/news/3645413-arbutus-biopharma-initiated-buy-h-c-wainwright-on-abminus-720-being-significant-stock

Ampio IV Ampion demonstrates safety in COVID-19 study

 

• Ampio Pharmaceuticals (AMPE +4.3%) has completed its Phase 1 clinical trial and has initiated the first steps for a global Phase 2 clinical trial for intravenous (IV) Ampion treatment in COVID-19 patients.
• Based on data review, the Safety Monitoring Committee found the IV treatment of Ampion to be safe and well-tolerated for 90-days following treatment.
• The study met its primary safety endpoint after 5 days of IV Ampion treatment and again after 3 months, with no remarkable safety differences between the Ampion treatment and SOC control groups.
• It also showed promising efficacy with the IV Ampion treatment group seeing stronger clinical improvement than the SOC group as measured by the World Health Organization clinical improvement scale and the National Early Warning Score.
• Additionally, Ampion-treated patients showed greater improvement compared to patients treated with the SOC, including anti-viral therapies.
• https://seekingalpha.com/news/3645460-ampio-pharmss-iv-ampion-demonstrates-safety-in-covidminus-19-study

Kiromic BioPharma files two IND applications for CAR-T therapy in cancer

 

• Nano-cap Kiromic BioPharma (KRBP +6.8%) has announced the submission of two investigational new drug (IND) applications with the FDA for the initiation of two separate Phase 1 trials of an allogenic CAR-T administered intravenously and intrapleural/intraperitoneal for the treatment of epithelial ovarian carcinoma and malignant pleural mesothelioma.
• Kiromic’s proprietary PD1 Gamma-delta CAR (PD1-GDT CAR) T cell therapy is “off-the-shelf” allogeneic CAR T cells derived from healthy donors.
• The initial dose escalation component of each CAR-T trial is projected to enroll approximately 12 patients over 4 months at two sites. First in-human dosing is targeted for 1Q-2021.
• https://seekingalpha.com/news/3645464-kiromic-biopharma-files-two-ind-applications-for-car-t-therapy-in-cancer

Revance up on positive Daxi data in facial line study

 

• Revance Therapeutics (RVNC +6.7%) has announced positive efficacy and duration results from Phase 2 upper facial lines study, evaluating Daxibotulinumtoxin A for Injection in the combined treatment of glabellar lines, forehead lines and crow’s feet lines.
• The trial showed efficacy of none or mild wrinkle severity in at least 92% of subjects at week 4.
• Median time to return to baseline wrinkle severity was at least 33 weeks (7.6 months).
• Treatment with Daxibotulinumtoxin A for Injection was well tolerated across upper facial regions
• Revance is currently awaiting a decision on the approval of Daxibotulinumtoxin A for Injection for the treatment of glabellar lines by FDA, pending a manufacturing site inspection, which was delayed due to Covid-19 travel restrictions.
• https://seekingalpha.com/news/3645405-revance-stock-climbs-on-positive-daxi-data-in-facial-line-study

FDA clears first implant for healing torn ACLs

 For the first time, the FDA has cleared a unique type of implant to repair torn anterior cruciate ligaments (ACLs), allowing patients to avoid reconstruction procedures that may require tendons to be taken from other joints in the body.

Miach Orthopedics’ bioengineered BEAR implant provides a structure within the knee that assists the torn ends of the ligament in healing back together themselves. 

Tears in the ACL—which spans the front to the back of the knee and helps keep the joint stable—are some of the most common sports injuries in the U.S., with about 400,000 happening each year, according to the company.

Repair surgeries typically involve replacing the ACL with healthy tendons taken from elsewhere in the patient’s leg or by using tissue from a donor, or simply by sewing it with sutures. However, as many as 1 in 5 teenagers will still re-tear their ACL, and only about 60% of patients may return to their sport at the same competitive level.

After being placed, the BEAR’s collagen structure is slowly absorbed back into the body over about two months, as the wound begins to mend. The spongelike implant also holds a small amount of the patient’s blood at the site of the tear—an important feature, as the fluid that lubricates the knee joint can also interfere with blood clotting, stopping ACLs from healing naturally. 

In clinical trials that tracked participants for at least two years after a repair procedure and physical therapy, those who received the BEAR implant reported similar levels of knee function, pain, stiffness and sports activity compared to patients who had their ACLs grafted with their own tendons. The two groups also had similar measures of the looseness of the joint when compared to the uninjured leg, according to the FDA.

The agency granted the BEAR implant a de novo clearance for skeletally mature patients at least 14 years old who have a complete rupture of the ACL confirmed by an MRI scan.

https://www.fiercebiotech.com/medtech/fda-clears-first-implant-for-healing-torn-acls