IQVIA

ANI Pharmaceuticals Announces the FDA Approval and Launch of Estradiol Gel, 0.1%

Retrieved on: 
Monday, August 28, 2023
Abbreviated New Drug Application, ANI, Food and Drug Administration, RLD, Patient, Estradiol valerate, ANDA, FDA, Food, Generic drug, IQVIA

BAUDETTE, Minn., Aug. 28, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Gel, 0.1%.

Key Points: 
  • BAUDETTE, Minn., Aug. 28, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Gel, 0.1%.
  • ANI’s Estradiol Gel, 0.1%, is the generic version of the Reference Listed Drug (RLD) Divigel®.
  • The current annual U.S. market for Estradiol Gel, 0.1%, is approximately $42.3 million, according to IQVIA, a leading healthcare data and analytics provider.
  • "The approval and launch of Estradiol Gel, 0.1%, mark an important milestone for ANI, as this is the first topical gel approved from our R&D and manufacturing site in New Jersey.

Roivant Reports Financial Results for the First Quarter Ended June 30, 2023, and Provides Business Update

Retrieved on: 
Monday, August 14, 2023
Sarcoidosis, Lupus, CIDP, SG, DM, IQVIA, Calendar, Myasthenia gravis, NIU, Prescription, Atopic dermatitis, Research, GD, SLE, Pharmacy, Ulcerative colitis, Psoriasis, MDS, Acquisition, Patient, Transfusion-dependent anemia, Drug discovery, R, FDA, Safety, TED, Pharmaceutical industry, Life insurance, Cryptocurrency, Dermatomyositis, Roivant Sciences

Dermavant: For the first quarter ended June 30, 2023, Roivant reported VTAMA net product revenue of $16.7M, representing a 26% gross-to-net yield for the quarter.

Key Points: 
  • Dermavant: For the first quarter ended June 30, 2023, Roivant reported VTAMA net product revenue of $16.7M, representing a 26% gross-to-net yield for the quarter.
  • First Quarter Ended June 30, 2023, Financial Summary
    As of June 30, 2023, the company had consolidated cash, cash equivalents and restricted cash of $1.4 billion.
  • Net loss was $327.8 million for the three months ended June 30, 2023, compared to $353.8 million for the three months ended June 30, 2022.
  • Non-GAAP net loss was $211.5 million for the three months ended June 30, 2023, compared to $210.7 million for the three months ended June 30, 2022.

RenovoRx Reports Second Quarter 2023 Financial Results and Operational Highlights

Retrieved on: 
Thursday, August 17, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, SAB, Pancreatic cancer, University of Texas Southwestern Medical Center, PPD, IQVIA, University, Senior, Gastrointestinal cancer, TAMP, Evotec, Schering-Plough, Neoplasm, ESMO, New Drug Application, Survival, NDA, Coronavirus Scientific Advisory Board, ASX, Immunotherapy, IMU, MD, Patient, Research, FDA, D, Pharmaceutical industry, Cryptocurrency

(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, today announced financial results for the second quarter ended June 30, 2023.

Key Points: 
  • (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing targeted combination therapies, today announced financial results for the second quarter ended June 30, 2023.
  • Second Quarter 2023 Financial Results:
    Cash Position: Cash and cash equivalents as of June 30, 2023, were $6.0 million.
  • G&A Expenses: General and administrative expenses were $1.4 million for the second quarter ended June 30, 2023, compared to $1.2 million for the quarter ended June 30, 2022.
  • Net Loss: Net loss was $2.3 million for the quarter ended June 30, 2023, compared to net loss of $2.6 million for the quarter ended June 30, 2022.

FDA Accepts MyMD Pharmaceuticals’ Investigational New Drug Application (IND) for Phase 2 Study of oral TNF-α inhibitor MYMD-1® in Rheumatoid Arthritis (RA)

Retrieved on: 
Monday, August 14, 2023
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Infection, RA, TNF, Hospital, IQVIA, Facial muscles, Disability, Pharmacokinetics, IL-6, Inflammation, Biomarker, Sarcopenia, Rheumatoid arthritis, MD, Patient, Swelling, Risk, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, News, Food, Safety, Pharmaceutical industry

MYMD-1 is an oral, next-generation TNF-α inhibitor with the potential to transform the way TNF-α based diseases are treated due to its selectivity and ability to cross the blood brain barrier.

Key Points: 
  • MYMD-1 is an oral, next-generation TNF-α inhibitor with the potential to transform the way TNF-α based diseases are treated due to its selectivity and ability to cross the blood brain barrier.
  • Its ease of oral dosing is a significant differentiator compared to currently available TNF-α inhibitors, all of which require delivery by injection or infusion.
  • MYMD-1 has also been shown to selectively block TNF-α action where it is overactivated without preventing it from doing its normal job of responding to routine infection.
  • In addition, in early clinical studies it has not been associated with serious side effects known to occur with traditional immunosuppressive therapies that treat inflammation.

Between June and July, New York Residential Closed Median Sale Price Increases by 3.40%

Retrieved on: 
Friday, August 18, 2023
MLS, Catskill, Haggerty, Hudson Valley, Statistics, County, Multimedia, Sale, Multiple listing service, Condo, IQVIA, Real estate

FARMINGDALE, N.Y., Aug. 18, 2023 /PRNewswire/ -- OneKey® MLS is the one source real estate marketplace for monthly statistics for residential real estate transactions from Montauk to Manhattan, north through the Hudson Valley and the Catskill Mountains. For July 2023, OneKey MLS reported a regional closed median sale price of $633,000, a 3.40% increase as compared to the $612,000 reported in June 2023. In a year-over-year comparison, the closed median sale price rose slightly as well, increasing 2.10% from the $620,000 reported in July 2022. Between June 2023 and July 2023, closed regional sales transactions, including residential, condo, and co-op sales, decreased to 4,288 from 4,899, representing a month-over-month decrease of 26.00%. Across the region, pending sales transactions decreased in a month-over-month comparison, reportedly 4,642 in July 2023 as compared to the reported 5,313 in June 2023.

Key Points: 
  • For July 2023, OneKey MLS reported a regional closed median sale price of $633,000, a 3.40% increase as compared to the $612,000 reported in June 2023.
  • In a year-over-year comparison, the closed median sale price rose slightly as well, increasing 2.10% from the $620,000 reported in July 2022.
  • Seven of nine counties reported an increased closed median sale price in a month-over-month comparison, while two counties reported a decreased median sale price.
  • Putnam (+7.70%), Queens (+6.30 %), Nassau (+4.30 %), Westchester (+4.30%), Orange (+2.10%), Rockland (+2.10%), and Suffolk (+1.80%) Counties reported month-over-month increases in closed median sale price.

OneKey® MLS and Sullivan County Board of REALTORS® Strengthen Partnership

Retrieved on: 
Monday, August 14, 2023
MLS, Catskill Mountains, Partnership, Haggerty, Organization, Somatosensory system, Multiple listing service, CoreLogic, IQVIA, Real estate

FARMINGDALE, N.Y., Aug. 14, 2023 /PRNewswire/ -- OneKey® MLS is pleased to announce an agreement to continue our partnership with the Sullivan County Board of REALTORS®, which will provide more opportunities for members to grow their businesses. In addition to serving as SCBR's Multiple Listing Service, OneKey MLS will be a strong supporter and premier sponsor for SCBR's initiatives and events.

Key Points: 
  • FARMINGDALE, N.Y., Aug. 14, 2023 /PRNewswire/ -- OneKey® MLS is pleased to announce an agreement to continue our partnership with the Sullivan County Board of REALTORS®, which will provide more opportunities for members to grow their businesses.
  • In addition to serving as SCBR's Multiple Listing Service, OneKey MLS will be a strong supporter and premier sponsor for SCBR's initiatives and events.
  • In the spirit of cooperation, OneKey MLS will continue to focus on the synergies that have existed between the two organizations.
  • Sullivan County is the northern-most part of the OneKey MLS's footprint, adjacent to Ulster, Delaware, and Orange Counties.

IO Biotech Appoints Heidi Hunter to its Board of Directors

Retrieved on: 
Friday, August 11, 2023
Vaccine, University of Chicago Booth School of Business, Senior, Priyanka, University of Michigan, Marketing, IQVIA, Audit committee, Cancer, Business, Doctor of Philosophy, CNS, Sutro Biopharma, Boehringer Ingelheim, Cardinal Health, UCB, University, Novo Nordisk, Johnson & Johnson, FDA, BLA, Janssen Pharmaceuticals, Pharmaceutical industry, Novartis, Pfizer

NEW YORK, Aug. 11, 2023 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win® technology platform, announced the appointment of Heidi Hunter to its board of directors.

Key Points: 
  • NEW YORK, Aug. 11, 2023 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win® technology platform, announced the appointment of Heidi Hunter to its board of directors.
  • In addition, Priyanka Belawat, PhD, has announced that she is stepping down from the company’s board of directors, effective immediately.
  • “We are delighted to welcome Heidi to the IO Biotech Board,” said Mai-Britt Zocca, PhD, President and CEO of IO Biotech.
  • Ms. Hunter also held senior leadership positions in commercial and strategic marketing for biologics and oncology at Centocor, a Johnson & Johnson company.

Vial Introduces Their Vice President of Ophthalmology, Amy Del Medico

Retrieved on: 
Friday, August 11, 2023
Retina, IQVIA, Clinical trial, Data collection, COVID, Strategic planning, Patient, ESourcing Capability Model, SAN, Entrepreneurship, EDC, Pharmaceutical industry, Vial, Ophthalmology

SAN FRANCISCO, Aug. 10, 2023 /PRNewswire/ -- Vial , a global tech-forward CRO proving next-generation clinical trial management services, announced the appointment of Amy Del Medico as their Vice President of Ophthalmology.

Key Points: 
  • SAN FRANCISCO, Aug. 10, 2023 /PRNewswire/ -- Vial , a global tech-forward CRO proving next-generation clinical trial management services, announced the appointment of Amy Del Medico as their Vice President of Ophthalmology.
  • Amy brings with her an extensive background of over two decades in strategic planning for U.S. and global clinical trials.
  • Simon Burns, CEO and Co-Founder of Vial, shared his thoughts on Amy's impact: "We are delighted to welcome Amy to Vial as our VP of Ophthalmology.
  • With Amy on board, we are poised to drive innovation and deliver ground-breaking therapies to benefit sponsors and patients worldwide."

Sol-Gel Technologies Reports Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, August 10, 2023
Partnership, Prescription, Acne, Trial of the century, Orphan drug, Dermatology, Acquisition, Patient, Rosacea, NESS, Sol–gel process, Research, Carcinoma, Nevoid basal-cell carcinoma syndrome, Breakthrough, Pharmaceutical industry, IQVIA

“We were pleased to announce another TWYNEO and EPSOLAY partnership during the quarter which generated non-dilutive revenue for our shareholders.

Key Points: 
  • “We were pleased to announce another TWYNEO and EPSOLAY partnership during the quarter which generated non-dilutive revenue for our shareholders.
  • Patient refill rates have also remained consistent during the second quarter, indicating overall continued confidence and positive patient experience.
  • According to IQVIA data, there have been over 13,000 prescriptions of EPSOLAY written in the second quarter of 2023, and over 50,000 prescriptions written to date.
  • The balance as of June 30, 2023 includes $10 million received in April 2023 as part of the $22.8 million raised in the recent financing.

Corium and Lotus Pharmaceutical Enter into Exclusive License Agreement for Innovative Alzheimer's Disease Treatment ADLARITY® in Multiple Markets Across Asia

Retrieved on: 
Thursday, August 10, 2023
Health, Genetics, Managed Care, Clinical Trials, Pharmaceutical, Biotechnology, Hypersensitivity, Cholinesterase, Nausea, Bethanechol, Bradycardia, Peptic ulcer disease, Asthma, Neuromuscular blocking agents, Cholinergic, Partnership, Alzheimer's disease, Diarrhea, Gastrointestinal tract, IQVIA, Roflumilast, Skin, History, Orthostatic syncope, CNS, Heart block, Dementia, Tablet, Anesthesia, Vomiting, Enzyme inhibitor, Incidence, Patient, Chloride, Gastrointestinal bleeding, Nonsteroidal anti-inflammatory drug, FDA, Relaxation, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cholinesterase inhibitor, Safety, Food, Caregiver, Pharmaceutical industry, Residential care, Dietary supplement, Corium, Donepezil, Lotus

Corium, LLC (“Corium”), a commercial-stage biopharmaceutical company leading the development and commercialization of novel neuroscience therapies, and Lotus Pharmaceutical (1795:TT; “Lotus”), a multinational pharmaceutical company, announced that the companies have entered into an exclusive Collaboration and License Agreement for ADLARITY® (donepezil transdermal system), an innovative Alzheimer’s dementia treatment, in ten markets across Asia.

Key Points: 
  • Corium, LLC (“Corium”), a commercial-stage biopharmaceutical company leading the development and commercialization of novel neuroscience therapies, and Lotus Pharmaceutical (1795:TT; “Lotus”), a multinational pharmaceutical company, announced that the companies have entered into an exclusive Collaboration and License Agreement for ADLARITY® (donepezil transdermal system), an innovative Alzheimer’s dementia treatment, in ten markets across Asia.
  • The companies expect to file for regulatory approval in some Asian markets later this year.
  • Under the terms of the agreement, Lotus will have exclusive rights to commercialize ADLARITY® in the applicable territory and will be responsible for the regulatory approval process.
  • According to IQVIA data, the market size of donepezil in the 10 markets in the territory is USD 185 Million.