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AstraZeneca India recasts biopharma unitOn June 1, 2020, Emergent announced a $628 million contract with the U.S. government to produce COVID-19 vaccines. The company started producing vaccine materials for Johnson & Johnson and AstraZeneca at its Baltimore facility in late 2020. In March 2021, the facility accidentally contaminated Johnson & Johnson vaccine doses with AstraZeneca ingredients. By April 2021, the FDA halted production at the site, citing quality issues, contamination risks, and poor training. Following the contamination crisis, Emergent stock price dropped by over 60% by November 2021, erasing over half the company’s market value in just months. Shortly after, shareholders filed multiple lawsuits against Emergent, claiming the company misrepresented its vaccine production capabilities and hid serious quality issues. Emergent BioSolutions recently agreed to pay a $40 million settlement to investors to resolve the lawsuits. Affected investors can now file a claim to receive the payout. Overview Emergent BioSolutions EBS secured over $1 billion in government and pharmaceutical contracts during the COVID-19 pandemic. However, in March 2021, workers at its Baltimore facility mistakenly mixed Johnson & Johnson and AstraZeneca vaccine ingredients, contaminating up to 15 million J&J doses and forcing AstraZeneca to discard tens of millions more. This error delayed J&J's vaccine rollout and disrupted global distribution, causing Emergent stock to drop by over 50% by November 2021. Following these events, a group of shareholders sued Emergent, and recently, Emergent agreed to pay a $40 million settlement to all affected investors. How It All Started: Manufacturing Failures In the wake of the COVID-19 pandemic, Emergent BioSolutions positioned its Bayview facility as a critical vaccine production asset. In March 2020, the company secured over $1 billion in contracts with Johnson & Johnson and AstraZeneca, including a substantial government Operation Warp Speed contract. On April 30, 2020, CEO Robert Kramer declared during an earnings call that the company had “proven manufacturing capabilities” and was prepared to scale up quickly to meet the demands of vaccine production. In July 2020, following the AstraZeneca agreement, Emergent further bolstered its claims in a press release, with Kramer declaring, “ Emergent is driven by our desire to advance solutions that will make an impact on this pandemic “. The company’s CDMO business unit head, Syed T. Husain, added that “ Emergent stands ready alongside leading innovators to rapidly deploy our CDMO services to help meet the substantial demand for a vaccine. “ By early 2021, Emergent shares were trading above $90, fueled by high expectations for the company's role in vaccine production. However, despite positive public messaging, internal audits and inspections in the summer of 2020 uncovered serious issues at Emergent BioSolutions' manufacturing facilities. Reports highlighted poor staff training, equipment failures, and inadequate quality control measures, revealing long-standing problems within the company’s operations. One audit found that “the flow of workers and materials through the plant was not adequately controlled to prevent mix-ups or contamination.” Another audit discovered that a manager had “knowingly deviated” from standard procedures. After that, in November 2020, AstraZeneca representatives visiting Emergent’s Bayview facility raised concerns about poor oversight and GMP compliance. Emergent’s VP of Manufacturing acknowledged these issues, mentioning trash buildup in hallways and lapses in GMP standards. An external consultant also warned that the facility was “NON-CGMP compliant” and at regulatory risk, but production still continued. Contamination Crisis at Emergent's Facility In March 2021, a major contamination incident at Emergent's Baltimore facility revealed significant oversight failures. Millions of Johnson & Johnson vaccine doses were mixed with AstraZeneca ingredients, an issue initially detected by Johnson & Johnson's lab in the Netherlands, not Emergent. The contamination forced the disposal of tens of millions of AstraZeneca doses and delayed the delivery of approximately 100 million Johnson & Johnson doses during a critical phase of the pandemic. Following this disclosure, Emergent issued a press release, stating that their “quality control systems worked as designed” and that discarding a batch of bulk drug substance “occasionally happens during vaccine manufacturing.” However, that same day the Associated Press released FDA documents obtained through FOIA requests, revealing a history of quality control issues at Emergent’s facilities dating back to 2017. FDA leaders reported that the company “hired a lot of individuals not as familiar with vaccine manufacturing that did not have adequate training.” Inspectors found several issues at Emergent's facility, including mismanaged waste, peeling paint, and cluttered equipment. They also discovered that some quality checks were removed from vaccines before an FDA visit in February 2021. Later, it came to light that Emergent had been forced to destroy vaccine materials equivalent to nearly 400 million doses — much more than the previously reported 85 million. The situation worsened on November 4, 2021, when Emergent announced that the Department of Health and Human Services had cancelled its $628 million contract, requiring the company to reverse $86 million in Q3 2021 revenue and reduce its contract backlog by $180 million. The impact on investors was clear as Emergent's stock price dropped by over 60%, from more than $120 in early 2021 to below $45 by November 2021. These disclosures and the sharp drop in stock price led shareholders to file multiple lawsuits against Emergent, accusing the company of misrepresenting its vaccine production capabilities and concealing serious quality issues. Resolving The Case After three years of legal proceedings, in September 2024, Emergent agreed to pay $40 million to settle the lawsuit from shareholders. If you invested in Emergent, you may be eligible to file for a portion of the settlement to recover your losses. As of now, Emergent BioSolutions has made significant progress in its recovery, securing a $50 million settlement with Johnson & Johnson and driving a broader transformation under CEO Joe Papa. In Q3 2024, the company saw a 9% revenue increase to $293.8 million and secured vital government contracts, including a $250 million order to produce vaccines for anthrax, botulism, and smallpox. It also sold its Camden facility for $30 million to streamline operations. However, its stock remains far below previous highs, trading at $8 in November 2024 — a 93.6% decline from its $125 peak in 2021, showing that there is still a long road ahead for a recovery. © 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Germany to tighten criminal law as people-smuggling ‘action plan’ agreed with UKThe Reserve Bank of India 's ( RBI ) move to draw capital flows by allowing banks to offer higher interest rates for foreign currency deposits for a specific period appears to have had few takers in the three weeks since the plan's announcement. Bankers said the rupee's recent sharp fall and a narrowing in the interest rate gap between the US and India will make it even more difficult to attract depositors. ET Year-end Special Reads What kept India's stock market investors on toes in 2024? India's car race: How far EVs went in 2024 Investing in 2025: Six wealth management trends to watch out for In its December monetary policy, the RBI temporarily raised the ceiling on interest rates banks can offer on foreign currency non-resident accounts or FCNR (B) deposits. Yet, the relevant pages on their respective websites showed that none of the commercial lenders raised interest rates since the central bank gave them the leeway. The RBI allowed banks to raise deposits at a spread of 400 basis points over an Alternate Reference Rate (ARR) for one to three years as against 250 bps spread earlier. For deposits between three and five years, the spread is raised to 500 bps over ARR against a cap of 350 bps. One basis point is a hundredth of a percentage point. "Banks were generally not even offering deposits close to the earlier ceiling," said Madan Sabnavis, chief economist at Bank of Baroda . "Hence, the new ceiling has not made much difference for most banks." 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"Some of the niche private banks will find this useful as they cater more to the expat population. Banks typically match such deposits with foreign currency loan requirements," Sabnavis said. "With this being stable at lower levels, it may not be economical given that the rupee is falling and forex risk is borne by banks." Forex Stockpile The RBI's move to raise the ceiling is to shore up foreign exchange (forex) reserves, which have fallen by $60 billion after touching an all-time high of $706 billion at the end of September. The forex reserves have declined as the RBI is selling dollars to support the rupee, which has consistently weakened against the greenback and hit new record lows of 85.80 Friday. Bankers say the existing spreads of 250-350 bps already offer sufficient flexibility and room for banks to adjust FCNR rates upward. "The spread between US and Indian interest rates has narrowed to its lowest level in recent years, making Indian foreign currency deposits less appealing to the Indian diaspora," said VRC Reddy, head of treasury, Karur Vysya Bank . "On the other hand, demand for export credit in rupee terms remains robust due to interest subvention benefits for MSME borrowers, reducing the attractiveness of borrowing in foreign currency for export credit, particularly when hedging costs are factored in. Even when using FX deposits for rupee-based purposes, the landed cost often exceeds that of rupee deposits, further limiting their appeal." Rather, many banks are offering rates that are lower than the earlier ceiling. The ARR for dollar deposits is pegged around 4.24% for December and an increase in the ceiling by 400 bps allows lenders to offer 8.24% on dollar deposits. However, most banks are offering just about 150-200 bps above the ARR. For instance, the State Bank of India (SBI) is giving savers 5.35% on one-year rate dollar deposits under the FCNR (B) scheme, and the rate has remained the same since mid-October. This shows the rates are lower than the previous spread of 250 bps. SBI offers 3.90% for five FCNB (B) deposits, which is still lower than the revised 500 bps spread. The revised caps announced in the monetary policy review are applicable only until the end of March 2025. "The cash reserve ratio (CRR) exemption on incremental FCNR deposits may encourage banks to raise FCNR deposit rates, thereby attracting more foreign exchange flows-an essential measure in the current economic context," Reddy said. Foreign currency deposits mobilised by banks in rupee equivalent stood at ₹1.98 lakh crore as of March 31, 2024, up 46% over the previous financial year, according to the latest Trends and Progress of Banking report published last week. In 2013, the then governor, Raghuram Rajan, launched the FCNR (B) plan, wherein the RBI effectively provided banks with a cushion against risks of adverse currency movements through the period of a committed deposit. This programme helped banks mobilise nearly $30 billion in overseas deposits. Nominations for ET MSME Awards are now open. The last day to apply is December 31, 2024. Click here to submit your entry for any one or more of the 22 categories and stand a chance to win a prestigious award. (You can now subscribe to our Economic Times WhatsApp channel )None
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The Central Bank of Egypt (CBE) has issued a directive mandating banks to include simplified forms in contracts for banking products and services. These forms, provided as appendices, will outline the essential details of the offered products or services, including all associated expenses, commissions, and key terms and conditions. This move aims to enhance transparency and ensure customers have a clear understanding of their banking agreements. To facilitate the implementation of this decision, banks have been granted a six-month grace period to comply. According to the CBE, these appendices must also include any new provisions not originally specified in the contracts, provided that the customer’s consent is obtained through a signature. This ensures that any updates or changes to the agreement are clearly communicated and acknowledged. The CBE emphasized the importance of declaring customers’ financial rights, including the value of commissions and expenses for any banking product, as well as the applicable interest rates. Customers must also be informed of any changes to these rates in a timely manner. In addition, customers have the right to: The CBE also issued a warning to customers against sharing personal or banking information. It stressed that banks will never request such information through phone calls, text messages, emails, or social media platforms. This reminder aims to safeguard customers against fraud and unauthorized access to their financial data. This new regulation underscores the CBE’s commitment to protecting consumer rights and fostering a more transparent and secure banking environment in Egypt.Shoppers bemused as Easter eggs hit shop shelves before New Year’s Eve
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