Bengaluru: AbbVie on Thursday cut its 2025 adjusted profit forecast as the drugmaker expects to incur USD 248 million in acquisition expenses related to milestone payments as well as research and development costs.The company has been focusing on expanding its pipeline since its blockbuster arthritis drug, Humira, lost patent protection in 2023.Read also: Abbvie CEO Robert A Michael to assume additional role of Board ChairmanTo that end, the company bought neuroscience drug developer Cerevel Therapeutics, cancer drug developer ImmunoGen and Alzheimer's therapy developer Aliada in 2024 through deals worth over $20 billion in total.AbbVie expects adjusted annual profit in the range of $11.99 to $12.19 per share, compared with its previous forecast of $12.12 to $12.32 per share.Analysts on average were expecting full-year profit to be $12.30 per share, according to data compiled by LSEG.The company also expects first-quarter adjusted profit of $2.34 to $2.38 per share, compared with Wall Street estimates of $2.51 per share.AbbVie is scheduled to report first-quarter earnings on April 25.

Basel: Novartis has announced the appointment of Karen Hale to the expanded role of Chief Legal and Compliance Officer for Novartis, effective April 14, 2025. She will continue to report to Vas Narasimhan, M.D., CEO of Novartis and remain on the Executive Committee of Novartis (ECN).

Klaus Moosmayer, currently Chief Ethics, Risk & Compliance Officer of Novartis, has decided to leave the company and will step down from the ECN to pursue his next chapter of leadership outside Novartis. The current Ethics Risk & Compliance (ERC) function will move under the leadership of Karen Hale.“Klaus has been integral to building trust with society by solving our legacy compliance topics and putting an ethics, risk and compliance system in place, which is regarded highly internally and externally. The impact he has had on our company, our people and our reputation will be long-lasting,” said Vas Narasimhan, CEO of Novartis. “I want to thank Klaus for his extraordinary leadership since he joined the company and ECN and wish him the very best as he pursues his next chapter. I have confidence that Karen will continue the strong commitment and rigor we have around ethics, risk management and compliance at Novartis.”Karen joined Novartis as Chief Legal Officer in May 2021, bringing almost 30 years of experience in resolving legal and compliance issues in the global pharmaceutical industry. Prior to joining Novartis, she held a succession of senior roles at AbbVie including vice president, deputy general counsel and chief ethics and compliance officer.“I am looking forward to leveraging the strengths of Legal and ERC to best align on risk management across the enterprise and to leading our efforts in ensuring our commitment to ethics, risk management, compliance and integrity remain unwavering,” said Karen Hale.Reflecting on his journey in ERC, Klaus Moosmayer shared, “after joining Novartis in 2018, I leave the company with a strong sense of pride on what we have accomplished together in strengthening our reputation and building a holistic integrated assurance system for Novartis.”

t and that third-quarter profit was going to be far below analysts' estimates, pushed shares down 5% on Friday.Read also: CVS Health CEO steps down amid financial challengesThe company is under pressure from investors, including activist Glenview Capital, to bring up the price of shares, which are down 24% in a year of record highs for the broader market and are nearly half of CVS's 2022 highs.Andrew Mok, a senior analyst at Barclays, said a leadership change "was largely expected given recent missteps." But he noted that Joyner's background does not feature health insurance or public company CEO experience, and pointed to "a leadership gap at Aetna that will likely need to be addressed near term."Four other analysts and investors also questioned Joyner's ability to turn around Aetna, which has struggled to rein in medical services costs affecting its Medicare Advantage insurance for people aged 65 and older. Its problems echo that of rivals in the same business, but are more pronounced.Executive Chairman Roger Farah said in a joint interview with Joyner that the board had been unanimous in selecting its new CEO, describing the succession planning as "very thorough.""Lots of thought went into this, lots of conversation," he added.In the interview, Joyner said he has the experience needed for the job and that he has already begun working to address the challenges confronting Aetna while in his previous role as a top executive at the company.He plans to hire his own management team, including to run Aetna, which had been overseen by Lynch after the previous leader, Brian Kane, left two months ago.Joyner pointed to his business initiatives including creating a new type of drug coverage for health plan customers and a new strategy for offering near copies of pricey biologic drugs.CHALLENGES AHEADHealth insurance companies typically aim to pay out about 80% of the premiums they collect for customer medical services. CVS said on Friday that the percentage of premiums spent on medical services had risen to 95%.That's a concern for investors like James Harlow, senior vice president at Novare Capital Management, which holds CVS shares. "I'm just not connecting the dots in terms of how Joyner coming in as CEO is going to solve those issues," he said.The move to appoint Joyner was largely a response to investors wanting a CEO change, according to Michael Ha, an analyst at Baird.Not all analysts were skeptical of the move.Joyner is remembered for turning around Caremark's business in the early 2000s, said Lisa Gill, an analyst at J.P. Morgan."David's direct management style and candor will be hugely valuable," Gill said.CVS said on Friday it had completed a strategic review and would sell non-core assets as well as close 271 retail pharmacies. Reuters had previously reported that it was considering splitting up pharmacy and insurance.In the interview, Farah addressed the potential for a breakup."There were some questions about whether or not the pieces or parts stick together," he said, "and I think our ongoing conclusion has been that it does and we just need to execute better."Read also: CVS Health to remove AbbVie rheumatoid arthritis drug Humira from some drug reimbursement lists in April

BOTOX Cosmetic is now the first and only product approved for four aesthetic treatment areas: forehead lines, frown lines, crow's feet, and platysma bands, marking its expansion beyond facial applications. "Research shows millions of consumers in the U.S. are extremely or very bothered by their platysma bands.6* Until now, treatment options have been limited and with this approval, there is a nonsurgical, injectable option to temporarily improve the look of vertical bands connecting the jaw and neck," said Darin J. Messina, Ph.D., Senior Vice President, Aesthetics R&D at Allergan Aesthetics. "This fourth indication for BOTOX Cosmetic represents true innovation. We're excited to open new doors for patients and providers, helping them to achieve their aesthetic goals."Read also: AbbVie seeks USFDA accelerated approval for telisotuzumab vedotin for previously treated non small cell lung cancerThe platysma is a thin muscle that stretches across the neck and lower face. When contracted, it can create visible neck bands and a less defined jawline. BOTOX Cosmetic treatment targets this muscle beneath the skin, temporarily reducing its activity to improve the appearance of the neck and jaw bands. Injections are administered along the jawline and vertical bands with one of the FDA-approved doses—26, 31, or 36 units—depending on the severity. Patients should consult a licensed aesthetic specialist to determine if this treatment is suitable for them."In my practice, the neck and lower face are always a standard part of my comprehensive aesthetic consultation. Many of my patients are often surprised by the significant impact that changes in these areas can have," said Dr. Terrence Keaney, board-certified dermatologist and pivotal clinical trial investigator. "With the approval of BOTOX Cosmetic for the treatment of platysma bands, including precise injection patterns and dosing, I can now confidently offer my patients a treatment option that can help deliver the results they are looking to achieve."Phase III clinical trials demonstrated a significant improvement in the appearance of platysma bands with BOTOX® Cosmetic compared to placebo (p<0.0001), meeting the primary endpoint. This was assessed by both investigators and participants. All secondary endpoints were also achieved, as measured by several validated patient-reported outcome (PRO) tools. In two studies, 65% and 62% of patients reported being "Very Satisfied" or "Satisfied" with their neck and jawline appearance 14 days after receiving 26, 31, or 36 units of BOTOX Cosmetic, compared to only 12% with placebo.Patients interested in BOTOX Cosmetic for platysma bands are encouraged to join Alle, the loyalty program from Allergan Aesthetics. Serving over seven million members across nearly 30,000 practices, Alle aims to educate consumers on aesthetic treatments and enhance practice operations. It offers a comprehensive rewards program, allowing members to earn points on over 50 treatments and brands, even beyond Allergan Aesthetics. Alle also offers flexible payment options through Alle Payment Plans, powered by Cherry, making aesthetic treatments more accessible.According to 2021 U.S. Census estimates, about 3.8% of respondents in a survey of 15,295 participants were "Very" or "Extremely Bothered" by their platysma bands, equating to nine million individuals. In clinical trials, a ≥2-grade improvement in platysma band severity was observed in 32% of patients with BOTOX Cosmetic compared to 2% with placebo in Study 1, and 31% versus 0% in Study 2, based on assessments at day 14.Payment options through Cherry Technologies are provided by various lenders, with terms, approval amounts, and promotional rates depending on eligibility. Iowa-specific loans are subject to unique criteria, with APR capped at 20.99%.Read also: AbbVie, FutureGen ink pact to develop Next-Generation Therapy for Inflammatory Bowel Disease

CVS Health to remove AbbVie rheumatoid arthritis drug Humira from some drug reimbursement lists in AprilCVS cut its financial expectations for the third time in August with all major pharmacy chains attempting to navigate a drastically changed landscape, facing competition online and elsewhere.Joyner, who will also join the company's board, most recently served as executive vice president of CVS Health, and president of CVS Caremark. He led the pharmacy services business, which provides solutions to employers, health plans and government entities and serves approximately 90 million members through Caremark, CVS Specialty, and other areas. Joyner has 37 years of health care and pharmacy benefit management experience.CVS Health also announced on Friday that Chairman Roger Farah will now be executive chairman."We believe David and his deep understanding of our integrated business can help us more directly address the challenges our industry faces, more rapidly advance the operational improvements our company requires, and fully realize the value we can uniquely create," Farah said in a statement.The Woonsocket, Rhode Island company's preliminary forecast is for third-quarter adjusted earnings of $1.05 to $1.10 per share, citing higher-than-expected medical cost trends. Analysts polled by FactSet predict earnings of $1.69 per share.Back in August CVS Health changed the leadership of its health insurance business as it continued to deal with escalating costs. At the time, the company named Lynch to lead its insurance segment, replacing Executive Vice President Brian Kane, who is left the company about a year after arriving.Rising claims from the company's Medicare Advantage coverage have hurt CVS Health for much of this year and contributed to repeated trimmings of its outlook for 2024. Medicare Advantage plans are privately run versions of the federal government's coverage program mainly for people age 65 and older.CVS Health also said in August that it has been hurt by a drop in quality ratings for those plans and pressure from Medicaid coverage it manages in several states.CVS Health's stock is down nearly 13% before the market open on Friday.Read also: Impact of Regular Aspirin Use on ASCVD Mortality in Adults with Elevated Lipoprotein(a) Levels

Shyamakant Giri is a business leader with over 25 years of strategic and operating experience in pharmaceuticals, devices, diagnostics and healthcare services in leading Indian and multinational organizations across Asia, Africa, MENA & LATAM markets. He possesses experience in creating new ventures and improving existing businesses, developing leaders, identifying opportunities for value creation, and executing with discipline. His specialties include Business Development, Operations, Strategy, Product Marketing, start-ups, and turnarounds.Read also: USFDA approves Gland Pharma Plerixafor InjectionGiri is currently serving as  the President (India Business & Emerging Markets) of Amneal Pharmaceuticals, responsible for the commercial expansion and growth in India and Rest of the World markets. Previously, Giri was associated with Rivaara Labs as the Chief Executive Officer. Earlier, Giri was associated in various roles with Abbott India, AbbVie (India Region) and Abbott Diagnostics for almost eighteen years (2002-2020). Mr. Giri started his professional career with Wockhardt Ltd. and was associated during the period 1999-2002.Giri has done his Master’s in Marketing Management from Jamnalal Bajaj Institute of Management Studies and also holds a Master’s degree in Science (Organic Chemistry) from Mumbai University. He completed his Executive Programme from INSEAD, Singapore and Executive Programme in Hospital Management from Indian Institute of Management, Ahmedabad. 

Consequent to appointment of new CEO of the Company, Srinivas Sadu shall continue to be the Executive Chairman of the Company effective January 15, 2025. Srinivas Sadu has been a Director on the Board since April 25, 2019. Srinivas Sadu is not debarred from holding the office of Director by virtue of any SEBI order or any other such authority.

Read also: Gland Pharma names Srinivas Sadu as Executive Chairman, CEO

Being the first generic to be approved and launched, the company is entitled to 180-day competitive generic therapy (CGT) exclusivity, Lupin said in its recent statement.Prednisolone Acetate Ophthalmic Suspension USP, 1% is a generic equivalent of Pred Forte Ophthalmic Suspension, 1% of AbbVie, Inc. and is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. Pred Forte had estimated annual sales of USD 198 million in the U.S. (IQVIA MAT August 2024).Read also: Lupin arm buys nine brands of Medical Nutritional Institute in South Africa“The launch of Prednisolone Acetate Ophthalmic Suspension is a milestone and is aligned with our commitment to enhancing access to innovative, affordable and quality healthcare solutions,” said Vinita Gupta, CEO, Lupin. “This will strengthen our ophthalmic portfolio and will benefit patients seeking effective treatment for steroid-responsive inflammation.”Read also: Lupin launches Mirabegron Extended-Release Tablets in US

Food and Drug Administration (FDA) for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression.

Approximately 85% of lung cancers are classified as NSCLC1 and despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths throughout the world. The c-Met protein is a receptor tyrosine kinase found to be overexpressed in approximately 25% of advanced EGFR wild type, nonsquamous NSCLC patients and is associated with a poor prognosis. Teliso-V is being evaluated within this patient population who currently have very limited treatment options.

"Patients with non-small cell lung cancer have unmet medical needs and oncologists are looking for new treatment options for these patients who unfortunately have a poor prognosis," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "We are hopeful that Teliso-V will be a differentiated treatment for certain patients as we look to elevate the standards of care in oncology."

In December 2021, Teliso-V was granted Breakthrough Therapy Designation by the FDA. The BLA submission is supported by data from Phase 2 LUMINOSITY trial (Study M14-239), an ongoing study designed to characterize the safety and efficacy of Teliso-V in c-Met overexpressing NSCLC populations. Data from the LUMINOSITY study were recently presented at the 2024 American Society of Clinical Oncology congress and topline data from this trial were shared in 2023. Teliso-V is being further evaluated as a monotherapy in patients with previously treated c-Met overexpressing NSCLC in the randomized Phase 3 confirmatory global study TeliMET NSCLC-01. Enrollment in the study is underway and continues across global clinical trial sites.

Read also: AbbVie, FutureGen ink pact to develop Next-Generation Therapy for Inflammatory Bowel Disease

On
his behalf, the award was received by the inventor, Dr. Mahesh Patel (Chief Scientific Officer - Drug
Discovery Research) during “Global Bio – India 2024” event held in New Delhi.
The award is in recognition of the highest level of innovation and research that led to successful
development of Nafithromycin (Miqnaf), which is the multi-drug resistant pathogen
active respiratory antibiotic for the treatment of Community-Acquired Bacterial Pneumonia.

Miqnaf(Nafithromycin) fulfils major unmet medical need as existing treatment based on
Azithromycin and Amoxicillin + Clavulanic acid have either developed resistance in contemporary
respiratory pathogens or lack the coverage of entire range of respiratory pathogens involved in Community-Acquired Bacterial Pneumonia.

As a result, many of these patients need to be
hospitalized due to limitations of current treatment options. With once-a-day, ultra-short, 3 daycourse of oral treatment, Miqnaf (Nafithromycin) would obviate the need of hospitalization for
many such patients.
Discovery and development of Nafithromycin at Wockhardt spanned over 12 years and involved
several Phase 1 and Phase 2 clinical studies which were conducted in USA and Europe.

Nafithromycin has successfully completed Phase III clinical trial in India and is awaiting DCGI
approval.
Globally, for the 1st time in 33 years, a new macrolide drug in the form of Miqnaf (Nafithromycin)
has been developed to treat millions of community respiratory infections through a convenient
home-based oral monotherapy.

Community Acquired Bacterial Pneumonia is one of the highest disease burden globally and in India,
responsible for high mortality, morbidity and hospitalization, particularly in children and older agepatients. India accounts for 23% of the global burden of pneumonia. The annual incidence of
Community-Acquired Bacterial Pneumonia in India is estimated to be 8-10 million infections. The
currently available drugs to treat Community acquired bacterial pneumonia majorly are
Azithromycin (>60% resistance) and Amoxicillin + Clavulanic which does not cover atypical
respiratory pathogens. Notably, atypical respiratory pathogens are implicated in >30% of
Community-Acquired Bacterial Pneumonia infections.

Read also: CDSCO Panel Approves Wockhardt's Protocol Amendment Proposal for antimicrobial drug Cefepime plus Zidebactam

In a release, Aurobindo Pharma highlighted that its revenue from operations also saw a significant boost, climbing to Rs 7,567 crore in the June quarter compared to Rs 6,851 crore in the corresponding quarter of the previous fiscal year. 

Commenting on the Company’s performance, Mr. K. Nithyananda Reddy, Vice-Chairman and Managing Director of the Company said: “We are pleased with our continued strong performance this quarter, with a significant top-line growth across all our business segments. Our profitability was sustained by improved gross margins and operational efficiencies, while ramping-up our recently commercialized plants. We are confident in our ability to achieve our growth targets for FY25.” 

US formulations (excluding Puerto Rico) revenue increased by 13.3% YoY to INR 3,555 Cr (USD 426 million). Europe formulations revenue increased by 7.9% YoY to INR 1,982 Cr (EUR 221 million)

Whereas, Growth Markets revenue increased by 49.2% YoY to INR 709 Cr (USD 85 million).

Read also: Aurobindo Pharma secures USFDA okay for generic version of Novo Nordisk Vagifem

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and  active pharmaceutical ingredients globally in over 150 countries.

The company has 29 manufacturing and packaging facilities that are approved by regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The Company’s     product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.

Read also: Aurobindo Pharma arm buys Ace Lab for Rs 17.91 crore